    [House Report 108-147]
    [From the U.S. Government Publishing Office]

    108th Congress                                            Rept. 108-147
                            HOUSE OF REPRESENTATIVES
     1st Session                                                     Part 3

    ======================================================================

                         PROJECT BIOSHIELD ACT OF 2003

                                    _______

                      July 8, 2003.--Ordered to be printed

                                    _______

    Mr. Cox, from the Select Committee on Homeland Security, submitted the
                                   following

                                  R E P O R T

                                 together with

                                ADDITIONAL VIEWS

                            [To accompany H.R. 2122]

        The Select Committee on Homeland Security, to whom was
    referred the bill (H.R. 2122) to enhance research, development,
    procurement, and use of biomedical countermeasures to respond
    to public health threats affecting national security, and for
    other purposes, having considered the same, report favorably
    thereon with an amendment and recommend that the bill as
    amended do pass.

                                    CONTENTS

                                                                       Page
    Purpose and Summary..............................................    17
    Background and Need for Legislation..............................    17
    Hearings.........................................................    18
    Committee Consideration..........................................    19
    Committee Votes..................................................    19
    Committee Oversight Findings.....................................    27
    Statement of General Performance Goals and Objectives............    27
    New Budget Authority, Entitlement Authority, and Tax Expenditures    27
    Congressional Budget Office Estimate.............................    27
    Federal Mandates Statement.......................................    27
    Advisory Committee Statement.....................................    27
    Constitutional Authority Statement...............................    28
    Applicability to Legislative Branch..............................    28
    Section-by-Section Analysis of the Legislation...................    28
    Changes in Existing Law Made by the Bill, as Reported............    35

      The amendment is as follows:
      Strike all after the enacting clause and insert the
    following:

    SECTION 1. SHORT TITLE.

      This Act may be cited as the ``Project BioShield Act of 2003''.

    SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT AUTHORITIES.

      (a) In General.--Part B of title III of the Public Health Service Act
    (42 U.S.C. 243 et seq.) is amended by inserting after section 319F the
    following section:

    ``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
                        BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
                        ACTIVITIES.

      ``(a) In General.--
              ``(1) Authority.--In conducting and supporting research and
            development activities regarding biomedical countermeasures
            under section 319F(h), the Secretary may conduct and support
            such activities in accordance with this section if the
            activities concern qualified countermeasures.
              ``(2) Qualified countermeasure.--For purposes of this
            section, the term `qualified countermeasure' means a priority
            countermeasure (as defined in section 319F(h)) that affects
            national security.
              ``(3) Interagency cooperation.--
                      ``(A) In general.--In carrying out activities under
                    this section, the Secretary is authorized, subject to
                    subparagraph (B), to enter into interagency agreements
                    and other collaborative undertakings with other
                    agencies of the United States Government.
                      ``(B) Limitation.--An agreement or undertaking under
                    this paragraph shall not authorize another agency to
                    exercise the authorities provided by this section.
              ``(4) Availability of facilities to the secretary.--In any
            grant or cooperative agreement entered into under the authority
            provided in this section with respect to a biocontainment
            laboratory or other related or ancillary specialized research
            facility that the Secretary determines necessary for the
            purpose of performing, administering, and supporting qualified
            countermeasure research and development, the Secretary may
            provide that the facility that is the object of such grant or
            cooperative agreement shall be available as needed to the
            Secretary to respond to public health emergencies affecting
            national security.
      ``(b) Expedited Procurement Authority.--
              ``(1) Increased simplified acquisition threshold for
            biomedical countermeasure procurements.--
                      ``(A) In general.--For any procurement by the
                    Secretary of property or services for use (as
                    determined by the Secretary) in performing,
                    administering, or supporting qualified countermeasure
                    research or development activities under this section
                    that the Secretary determines necessary to respond to
                    pressing research and development needs under this
                    section, the amount specified in section 4(11) of the
                    Office of Federal Procurement Policy Act (41 U.S.C.
                    403(11)), as applicable pursuant to section 302A(a) of
                    the Federal Property and Administrative Services Act of
                    1949 (41 U.S.C. 252a(a)), shall be deemed to be
                    $25,000,000 in the administration, with respect to such
                    procurement, of--
                              ``(i) section 303(g)(1)(A) of the Federal
                            Property and Administrative Services Act of
                            1949 (41 U.S.C. 253(g)(1)(A)) and its
                            implementing regulations; and
                              ``(ii) section 302A(b) of such Act (41 U.S.C.
                            252a(b)) and its implementing regulations.
                      ``(B) Application of certain provisions.--
                    Notwithstanding subparagraph (A) and the provision of
                    law and regulations referred to in such subparagraph,
                    each of the following provisions shall apply to
                    procurements described in this paragraph to the same
                    extent that such provisions would apply to such
                    procurements in the absence of subparagraph (A):
                              ``(i) Chapter 37 of title 40, United States
                            Code (relating to contract work hours and
                            safety standards).
                              ``(ii) Subsections (a) and (b) of Section 7
                            of the Anti-Kickback Act of 1986 (41 U.S.C.
                            57(a) and (b)).
                              ``(iii) Section 304C of the Federal Property
                            and Administrative Services Act of 1949 (41
                            U.S.C. 254d) (relating to the examination of
                            contractor records).
                      ``(C) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal controls
                    for procurements that are under this paragraph,
                    including requirements with regard to documenting the
                    justification for use of the authority in this
                    paragraph.
              ``(2) Use of noncompetitive procedures.--In addition to any
            other authority to use procedures other than competitive
            procedures, the Secretary may use such other procedures when--
                      ``(A) the procurement is as described by paragraph
                    (1); and
                      ``(B) the property or services needed by the
                    Secretary are available from only one responsible
                    source or only from a limited number of responsible
                    sources, and no other type of property or services will
                    satisfy the Secretary's needs.
              ``(3) Increased micropurchase threshold.--
                      ``(A) In general.--For a procurement described by
                    paragraph (1), the amount specified in subsections (c),
                    (d), and (f) of section 32 of the Office of Federal
                    Procurement Policy Act (41 U.S.C. 428) shall be deemed
                    to be $15,000 in the administration of that section
                    with respect to such procurement.
                      ``(B) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal controls
                    for purchases that are under this paragraph and that
                    are greater than $2,500.
                      ``(C) Exception to preference for purchase card
                    mechanism.--No provision of law establishing a
                    preference for using a Government purchase card method
                    for purchases shall apply to purchases that are under
                    this paragraph and that are greater than $2,500.
      ``(c) Authority to Expedite Peer Review.--
              ``(1) In general.--The Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under this
            section, employ such expedited peer review procedures
            (including consultation with appropriate scientific experts) as
            the Secretary, in consultation with the Director of NIH, deems
            appropriate to obtain assessment of scientific and technical
            merit and likely contribution to the field of qualified
            countermeasure research, in place of the peer review and
            advisory council review procedures that would be required under
            sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492,
            and 494, as applicable to a grant, contract, or cooperative
            agreement--
                      ``(A) that is for performing, administering, or
                    supporting qualified countermeasure research and
                    development activities; and
                      ``(B) the amount of which is not greater than
                    $1,500,000.
              ``(2) Subsequent phases of research.--The Secretary's
            determination of whether to employ expedited peer review with
            respect to subsequent phases of a research grant or cooperative
            agreement under this section shall be determined without regard
            to the peer review procedures used for any prior peer review of
            that same grant or cooperative agreement.
      ``(d) Authority for Personal Services Contracts.--
              ``(1) In general.--For the purpose of performing,
            administering, and supporting qualified countermeasure research
            and development activities, the Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under this
            section, obtain by contract (in accordance with section 3109 of
            title 5, United States Code, but without regard to the
            limitations in such section on the period of service and on
            pay) the personal services of experts or consultants who have
            scientific or other professional qualifications, except that in
            no case shall the compensation provided to any such expert or
            consultant exceed the daily equivalent of the annual rate of
            compensation for the President.
              ``(2) Federal tort claims act coverage.--
                      ``(A) In general.--A person carrying out a contract
                    under paragraph (1), and an officer, employee, or
                    governing board member of such person, shall be deemed
                    to be an employee of the Department of Health and Human
                    Services for purposes of claims under sections 1346(b)
                    and 2672 of title 28, United States Code, for money
                    damages for personal injury, including death, resulting
                    from performance of functions under such contract.
                      ``(B) Exclusivity of remedy.--The remedy provided by
                    subparagraph (A) shall be exclusive of any other civil
                    action or proceeding by reason of the same subject
                    matter against the person, officer, employee, or
                    governing board member.
              ``(3) Internal controls to be instituted.--
                      ``(A) In general.--The Secretary shall institute
                    appropriate internal controls for contracts under this
                    subsection, including procedures for the Secretary to
                    make a determination of whether a person, or an
                    officer, employee, or governing board member of a
                    person, is deemed to be an employee of the Department
                    of Health and Human Services pursuant to paragraph (2).
                      ``(B) Determination of employee status to be final.--
                    A determination by the Secretary under subparagraph (A)
                    that a person, or an officer, employee, or governing
                    board member of a person, is or is not deemed to be an
                    employee of the Department of Health and Human Services
                    shall be final and binding on the Secretary and the
                    Attorney General and other parties to any civil action
                    or proceeding.
              ``(4) Number of personal services contracts limited.--The
            number of experts and consultants whose personal services are
            obtained under paragraph (1) shall not exceed 30 at any time.
      ``(e) Streamlined Personnel Authority.--
              ``(1) In general.--In addition to any other personnel
            authorities, the Secretary may, as the Secretary determines
            necessary to respond to pressing qualified countermeasure
            research and development needs under this section, without
            regard to such provisions of title 5, United States Code,
            governing appointments in the competitive service, and without
            regard to the provisions of chapter 51 and subchapter III of
            chapter 53 of such title relating to classification and General
            Schedule pay rates, appoint professional and technical
            employees, not to exceed 30 such employees at any time, to
            positions in the National Institutes of Health to perform,
            administer, or support qualified countermeasure research and
            development activities in carrying out this section.
              ``(2) Internal controls to be instituted.--The Secretary
            shall institute appropriate internal controls for appointments
            under this subsection.
      ``(f) Actions Committed to Agency Discretion.--Actions by the
    Secretary under the authority of this section are committed to agency
    discretion.''.
      (b) Technical Amendment.--Section 481A of the Public Health Service
    Act (42 U.S.C. 287a-2) is amended--
              (1) in subsection (a)(1), by inserting ``or the Director of
            the National Institute of Allergy and Infectious Diseases''
            after ``Director of the Center'';
              (2) in subsection (c)--
                      (A) in paragraph (1), by inserting ``or the Director
                    of the National Institute of Allergy and Infectious
                    Diseases'' after ``Director of the Center''; and
                      (B) in paragraph (2), in the matter preceding
                    subparagraph (A), by striking ``subsection (i)'' and
                    inserting ``subsection (i)(1)'';
              (3) in subsection (d), by inserting ``or the Director of the
            National Institute of Allergy and Infectious Diseases'' after
            ``Director of the Center'';
              (4) in subsection (e)--
                      (A) in paragraph (1)--
                              (i) in the matter preceding subparagraph (A),
                            by inserting ``or the Director of the National
                            Institute of Allergy and Infectious Diseases''
                            after ``Director of the Center'';
                              (ii) in subparagraph (A), by inserting ``(or,
                            in the case of the Institute, 75 percent)''
                            after ``50 percent''; and
                              (iii) in subparagraph (B), by inserting
                            ``(or, in the case of the Institute, 75
                            percent)'' after ``40 percent'';
                      (B) in paragraph (2), by inserting ``or the Director
                    of the National Institute of Allergy and Infectious
                    Diseases'' after ``Director of the Center''; and
                      (C) in paragraph (4), by inserting ``of the Center or
                    the Director of the National Institute of Allergy and
                    Infectious Diseases'' after ``Director'';
              (5) in subsection (f)--
                      (A) in paragraph (1), by inserting ``in the case of
                    an award by the Director of the Center,'' before ``the
                    applicant''; and
                      (B) in paragraph (2), by inserting ``of the Center or
                    the Director of the National Institute of Allergy and
                    Infectious Diseases'' after ``Director''; and
              (6) in subsection (i)--
                      (A) by striking ``Appropriations.--For the purpose of
                    carrying out this section,'' and inserting the
                    following: ``Appropriations.--
              ``(1) Center.--For the purpose of carrying out this section
            with respect to the Center,''; and
                      (B) by adding at the end the following:
              ``(2) National institute of allergy and infectious
            diseases.--For the purpose of carrying out this section with
            respect to the National Institute of Allergy and Infectious
            Diseases, there are authorized to be appropriated such sums as
            may be necessary for fiscal year 2003.''.

    SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

      (a) In General.--Part B of title III of the Public Health Service
    Act, as amended by section 2 of this Act, is amended by inserting after
    section 319F-1 the following section:

    ``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

      ``(a) Strategic National Stockpile.--
              ``(1) In general.--The Secretary of Homeland Security
            (referred to in this section as the `Homeland Security
            Secretary'), in coordination with the Secretary and the
            Secretary of Veterans Affairs, shall maintain a stockpile or
            stockpiles of drugs, vaccines and other biological products,
            medical devices, and other supplies in such numbers, types, and
            amounts as are determined by the Secretary to be appropriate
            and practicable, taking into account other available sources,
            to provide for the emergency health security of the United
            States, including the emergency health security of children and
            other vulnerable populations, in the event of a bioterrorist
            attack or other public health emergency.
              ``(2) Procedures.--The Secretary, in managing the stockpile
            under paragraph (1), shall--
                      ``(A) consult with the working group under section
                    319F(a);
                      ``(B) ensure that adequate procedures are followed
                    with respect to such stockpile for inventory management
                    and accounting, and for the physical security of the
                    stockpile;
                      ``(C) in consultation with Federal, State, and local
                    officials, take into consideration the timing and
                    location of special events;
                      ``(D) review and revise, as appropriate, the contents
                    of the stockpile on a regular basis to ensure that
                    emerging threats, advanced technologies, and new
                    countermeasures are adequately considered;
                      ``(E) devise plans for the effective and timely
                    supply-chain management of the stockpile, in
                    consultation with appropriate Federal, State and local
                    agencies, and the public and private health care
                    infrastructure; and
                      ``(F) ensure the adequate physical security of the
                    stockpile.
      ``(b) Smallpox Vaccine Development.--
              ``(1) In general.--The Secretary shall award contracts, enter
            into cooperative agreements, or carry out such other activities
            as may reasonably be required in order to ensure that the
            stockpile under subsection (a) includes an amount of vaccine
            against smallpox as determined by such Secretary to be
            sufficient to meet the health security needs of the United
            States.
              ``(2) Rule of construction.--Nothing in this section shall be
            construed to limit the private distribution, purchase, or sale
            of vaccines from sources other than the stockpile described in
            subsection (a).
      ``(c) Additional Authority Regarding Procurement of Certain
    Biomedical Countermeasures; Availability of Special Reserve Fund.--
              ``(1) In general.--
                      ``(A) Use of fund.--A security countermeasure may, in
                    accordance with this subsection, be procured with
                    amounts in the special reserve fund under paragraph
                    (10).
                      ``(B) Security countermeasure.--For purposes of this
                    subsection, the term `security countermeasure' means a
                    priority countermeasure (as defined in section
                    319F(h))--
                              ``(i) against a chemical, biological,
                            radiological, or nuclear agent identified as a
                            material threat under paragraph (2)(A)(ii);
                              ``(ii) that is determined under paragraph
                            (2)(B)(ii) to be a necessary countermeasure;
                              ``(iii) that is designed, developed,
                            modified, or procured for the specific purpose
                            of preventing, detecting, identifying,
                            deterring, or mitigating actual or potential
                            acts of chemical, biological, radiological, or
                            nuclear catastrophe;
                              ``(iv)(I) that is approved or cleared under
                            chapter V of the Federal Food, Drug, and
                            Cosmetic Act, or licensed under section 351 of
                            this Act, for use as a countermeasure to a
                            chemical, biological, radiological, or nuclear
                            agent identified as a material threat under
                            paragraph (2)(A)(ii); or
                              ``(II) for which the Secretary determines
                            that sufficient and satisfactory clinical
                            experience or research data (including data, if
                            available, from pre-clinical and clinical
                            trials) support a reasonable conclusion that
                            the countermeasure will qualify for approval or
                            licensing after the date of a determination
                            under paragraph (5); and
                              ``(v) that relates to an actual or potential
                            act of terrorism or catastrophic event or to
                            actual or potential warfare.
              ``(2) Determination of material threats.--
                      ``(A) Material threat.--The Homeland Security
                    Secretary, in consultation with the heads of other
                    agencies as appropriate, shall on an ongoing basis--
                              ``(i) assess current and emerging threats of
                            chemical, biological, radiological, and nuclear
                            agents; and
                              ``(ii) determine which of such agents present
                            a material threat against the United States
                            population.
                      ``(B) Public health impact; necessary
                    countermeasures.--The Secretary shall on an ongoing
                    basis--
                              ``(i) assess the potential public health
                            consequences of use against the United States
                            population of agents identified under
                            subparagraph (A)(ii); and
                              ``(ii) determine, on the basis of such
                            assessment, the agents for which priority
                            countermeasures are necessary to protect the
                            public health from a material threat.
                      ``(C) Notice to congress.--The Secretary and the
                    Homeland Security Secretary shall promptly notify the
                    designated congressional committees (as defined in
                    paragraph (10)) of any determination made pursuant to
                    subparagraph (A) or (B). Such notice shall be in
                    unclassified and, if necessary, classified form.
                      ``(D) Assuring access to threat information.--In
                    making the assessment and determination required under
                    subparagraph (A), the Homeland Security Secretary shall
                    use all information to which such Secretary is entitled
                    under section 202 of the Homeland Security Act of 2002,
                    including but not limited to information, regardless of
                    its level of classification, relating to current and
                    emerging threats of chemical, biological, radiological,
                    and nuclear agents.
              ``(3) Assessment of availability and appropriateness of
            countermeasures.--The Secretary, in consultation with the
            Homeland Security Secretary, shall assess on an ongoing basis
            the availability and appropriateness of specific
            countermeasures to address specific threats identified under
            paragraph (2).
              ``(4) Call for development of countermeasures; commitment for
            recommendation for procurement.--
                      ``(A) Proposal to the president.--If, pursuant to an
                    assessment under paragraph (3), the Homeland Security
                    Secretary and the Secretary make a determination that a
                    countermeasure would be appropriate but is either
                    currently unavailable for procurement or available
                    under unsuitable conditions, such Secretaries may
                    jointly submit to the President a proposal to--
                              ``(i) issue a call for the development of
                            such countermeasure; and
                              ``(ii) make a commitment that, upon the first
                            development of such countermeasure that meets
                            the conditions for procurement under paragraph
                            (5), the Secretaries will, based in part on
                            information obtained pursuant to such call,
                            make a recommendation under paragraph (6) that
                            the special reserve fund under paragraph (10)
                            be made available for the procurement of such
                            countermeasure.
                      ``(B) Countermeasure specifications.--The Homeland
                    Security Secretary and the Secretary shall, to the
                    extent practicable, include in the proposal under
                    subparagraph (A)--
                              ``(i) estimated quantity of purchase (in the
                            form of number of doses or number of effective
                            courses of treatments regardless of dosage
                            form);
                              ``(ii) necessary measures of minimum safety
                            and effectiveness;
                              ``(iii) estimated price for each dose or
                            effective course of treatment regardless of
                            dosage form; and
                              ``(iv) other information that may be
                            necessary to encourage and facilitate research,
                            development, and manufacture of the
                            countermeasure or to provide specifications for
                            the countermeasure.
                      ``(C) Presidential approval.--If the President
                    approves a proposal under subparagraph (A), the
                    Homeland Security Secretary and the Secretary shall
                    make known to persons who may respond to a call for the
                    countermeasure involved--
                              ``(i) the call for the countermeasure;
                              ``(ii) specifications for the countermeasure
                            under subparagraph (B); and
                              ``(iii) a commitment described in
                            subparagraph (A)(ii).
              ``(5) Secretary's determination of countermeasures
            appropriate for funding from special reserve fund.--
                      ``(A) In general.--The Secretary, in accordance with
                    the provisions of this paragraph, shall identify
                    specific security countermeasures that the Secretary
                    determines, in consultation with the Homeland Security
                    Secretary, to be appropriate for inclusion in the
                    stockpile under subsection (a) pursuant to procurements
                    made with amounts in the special reserve fund under
                    paragraph (10) (referred to in this subsection
                    individually as a `procurement under this subsection').
                      ``(B) Requirements.--In making a determination under
                    subparagraph (A) with respect to a security
                    countermeasure, the Secretary shall determine and
                    consider the following:
                              ``(i) The quantities of the product that will
                            be needed to meet the needs of the stockpile.
                              ``(ii) The feasibility of production and
                            delivery within five years of sufficient
                            quantities of the product.
                              ``(iii) Whether there is a lack of a
                            significant commercial market for the product
                            at the time of procurement, other than as a
                            security countermeasure.
              ``(6) Recommendation for president's approval.--
                      ``(A) Recommendation for procurement.--In the case of
                    a security countermeasure that the Secretary has, in
                    accordance with paragraphs (2), (3), and (5),
                    determined to be appropriate for procurement under this
                    subsection, the Homeland Security Secretary and the
                    Secretary shall jointly submit to the President, in
                    coordination with the Director of the Office of
                    Management and Budget, a recommendation that the
                    special reserve fund under paragraph (10) be made
                    available for the procurement of such countermeasure.
                      ``(B) Presidential approval.--The special reserve
                    fund under paragraph (10) is available for a
                    procurement of a security countermeasure only if the
                    President has approved a recommendation under
                    subparagraph (A) regarding the countermeasure.
                      ``(C) Notice to congress.--The Secretary and the
                    Homeland Security Secretary shall notify the designated
                    congressional committees of each decision of the
                    President to approve a recommendation under
                    subparagraph (A). Such notice shall include an
                    explanation of the decision to make available the
                    special reserve fund under paragraph (10) for
                    procurement of such a countermeasure, including, where
                    available, the identification of the potential supplier
                    or suppliers of such countermeasure, and whether other
                    potential suppliers of the same or similar
                    countermeasures were considered and rejected for
                    procurement under this section and the reasons
                    therefor.
                      ``(D) Subsequent specific countermeasures.--
                    Procurement under this subsection of a security
                    countermeasure for a particular purpose does not
                    preclude the subsequent procurement under this
                    subsection of any other security countermeasure for
                    such purpose if the Secretary has determined under
                    paragraph (5)(A) that such countermeasure is
                    appropriate for inclusion in the stockpile and if, as
                    determined by the Secretary, such countermeasure
                    provides improved safety or effectiveness, or for other
                    reasons enhances preparedness to respond to threats of
                    use of a biological, chemical, radiological, or nuclear
                    agent. Such a determination by the Secretary is
                    committed to agency discretion.
                      ``(E) Rule of construction.--Recommendations and
                    approvals under this paragraph apply solely to
                    determinations that the special reserve fund under
                    paragraph (10) will be made available for a procurement
                    of a security countermeasure, and not to the substance
                    of contracts for such procurement or other matters
                    relating to awards of such contracts.
              ``(7) Procurement.--
                      ``(A) In general.--For purposes of a procurement
                    under this subsection that is approved by the President
                    under paragraph (6), the Homeland Security Secretary
                    and the Secretary shall have responsibilities in
                    accordance with subparagraphs (B) and (C).
                      ``(B) Interagency agreements.--
                              ``(i) For procurement.--The Homeland Security
                            Secretary shall enter into an agreement with
                            the Secretary for procurement of a security
                            countermeasure in accordance with the
                            provisions of this paragraph. The special
                            reserve fund under paragraph (10) shall be
                            available for the Secretary's costs of such
                            procurement, other than as provided in clause
                            (ii).
                              ``(ii) For administrative costs.--The
                            agreement entered into between the Homeland
                            Security Secretary and the Secretary for
                            managing the stockpile under subsection (a)
                            shall provide for reimbursement of the
                            Secretary's administrative costs relating to
                            procurements under this subsection.
                      ``(C) Procurement.--
                              ``(i) In general.--The Secretary shall be
                            responsible for--
                                      ``(I) arranging for procurement of a
                                    security countermeasure, including
                                    negotiating terms (including quantity,
                                    production schedule, and price) of, and
                                    entering into, contracts and
                                    cooperative agreements, and for
                                    carrying out such other activities as
                                    may reasonably be required, in
                                    accordance with the provisions of this
                                    subparagraph; and
                                      ``(II) promulgating regulations to
                                    implement clauses (v), (vi), and (vii),
                                    and any other provisions of this
                                    subsection.
                              ``(ii) Contract terms.--A contract for
                            procurements under this subsection shall (or,
                            as specified below, may) include the following
                            terms:
                                      ``(I) Payment conditioned on
                                    substantial delivery.--The contract
                                    shall provide that no payment may be
                                    made until delivery has been made of a
                                    substantial portion (as determined by
                                    the Secretary) of the total number of
                                    units contracted for, except that,
                                    notwithstanding any other provision of
                                    law, the contract may provide that, if
                                    the Secretary determines (in the
                                    Secretary's discretion) that an advance
                                    payment is necessary to ensure success
                                    of a project, the Secretary may pay an
                                    amount, not to exceed 10 percent of the
                                    contract amount, in advance of
                                    delivery. The contract shall provide
                                    that such advance payment is required
                                    to be repaid if there is a failure to
                                    perform under the contract, except in
                                    special circumstances as determined by
                                    the Secretary on a contract by contract
                                    basis.
                                      ``(II) Contract duration.--The
                                    contract shall be for a period not to
                                    exceed five years, except that, in
                                    first awarding the contract, the
                                    Secretary may provide for a longer
                                    duration, not exceeding eight years, if
                                    the Secretary determines that
                                    complexities or other difficulties in
                                    performance under the contract justify
                                    such a period. The contract shall be
                                    renewable for additional periods, none
                                    of which shall exceed five years.
                                      ``(III) Storage by vendor.--The
                                    contract may provide that the vendor
                                    will provide storage for stocks of a
                                    product delivered to the ownership of
                                    the Federal Government under the
                                    contract, for such period and under
                                    such terms and conditions as the
                                    Secretary may specify, and in such case
                                    amounts from the special reserve fund
                                    under paragraph (10) shall be available
                                    for costs of shipping, handling,
                                    storage, and related costs for such
                                    product.
                                      ``(IV) Non-stockpile sales of
                                    security countermeasures.--The contract
                                    may provide that the vendor will not at
                                    any time (including after performance
                                    under the contract is otherwise
                                    completed) sell or otherwise provide
                                    such countermeasure to any domestic or
                                    foreign person, or transfer to any such
                                    person any quantity of such security
                                    countermeasure, or any intellectual
                                    property relating thereto that would
                                    enable the development or production of
                                    the countermeasure, without
                                    certification by the Secretary, in
                                    consultation with the Homeland Security
                                    Secretary, the Secretary of Defense,
                                    and the Secretary of State, that such
                                    sale or transfer, or category of sales
                                    or transfers, would not adversely
                                    affect the national security; and that,
                                    for each violation of this provision of
                                    the contract, the United States is
                                    entitled to recover from the person as
                                    liquidated damages an amount equal to
                                    three times the sum of the payments
                                    made to the vendor under the contract.
                              ``(iii) Availability of simplified
                            acquisition procedures.--
                                      ``(I) In general.--The amount of any
                                    procurement under this subsection shall
                                    be deemed to be below the threshold
                                    amount specified in section 4(11) of
                                    the Office of Federal Procurement
                                    Policy Act (41 U.S.C. 403(11)), for
                                    purposes of application to such
                                    procurement, pursuant to section
                                    302A(a) of the Federal Property and
                                    Administrative Services Act of 1949 (41
                                    U.S.C. 252a(a)), of--
                                              ``(aa) section 303(g)(1)(A)
                                            of the Federal Property and
                                            Administrative Services Act of
                                            1949 (41 U.S.C. 253(g)(1)(A))
                                            and its implementing
                                            regulations; and
                                              ``(bb) section 302A(b) of
                                            such Act (41 U.S.C. 252a(b))
                                            and its implementing
                                            regulations.
                                      ``(II) Application of certain
                                    provisions.--Notwithstanding subclause
                                    (I) and the provision of law and
                                    regulations referred to in such clause,
                                    each of the following provisions shall
                                    apply to procurements described in this
                                    clause to the same extent that such
                                    provisions would apply to such
                                    procurements in the absence of
                                    subclause (I):
                                              ``(aa) Chapter 37 of title
                                            40, United States Code
                                            (relating to contract work
                                            hours and safety standards).
                                              ``(bb) Subsections (a) and
                                            (b) of Section 7 of the Anti-
                                            Kickback Act of 1986 (41 U.S.C.
                                            57(a) and (b)).
                                              ``(cc) Section 304C of the
                                            Federal Property and
                                            Administrative Services Act of
                                            1949 (41 U.S.C. 254d) (relating
                                            to the examination of
                                            contractor records).
                              ``(iv) Use of noncompetitive procedures.--In
                            addition to any other authority to use
                            procedures other than competitive procedures,
                            the Secretary may use such other procedures for
                            a procurement under this subsection if the
                            product is available from only one responsible
                            source or only from a limited number of
                            responsible sources, and no other type of
                            product will satisfy the Secretary's needs.
                              ``(v) Premium provision in multiple award
                            contracts.--
                                      ``(I) In general.--If, under this
                                    subsection, the Secretary enters into
                                    contracts with more than one vendor to
                                    procure a security countermeasure, such
                                    Secretary may, notwithstanding any
                                    other provision of law, include in each
                                    of such contracts a provision that--
                                              ``(aa) identifies an
                                            increment of the total quantity
                                            of security countermeasure
                                            required, whether by percentage
                                            or by numbers of units; and
                                              ``(bb) promises to pay one or
                                            more specified premiums based
                                            on the priority of such
                                            vendors' production and
                                            delivery of the increment
                                            identified under item (aa), in
                                            accordance with the terms and
                                            conditions of the contract.
                                      ``(II) Determination of government's
                                    requirement not reviewable.--If the
                                    Secretary includes in each of a set of
                                    contracts a provision as described in
                                    subclause (I), such Secretary's
                                    determination of the total quantity of
                                    security countermeasure required, and
                                    any amendment of such determination, is
                                    committed to agency discretion.
                              ``(vi) Extension of closing date for receipt
                            of proposals not reviewable.--A decision by the
                            Secretary to extend the closing date for
                            receipt of proposals for a procurement under
                            this subsection is committed to agency
                            discretion.
                              ``(vii) Limiting competition to sources
                            responding to request for information.--In
                            conducting a procurement under this subsection,
                            the Secretary may exclude a source that has not
                            responded to a request for information under
                            section 303A(a)(1)(B) of the Federal Property
                            and Administrative Services Act of 1949 (41
                            U.S.C. 253a(a)(1)(B)) if such request has given
                            notice that the Secretary may so exclude such a
                            source.
              ``(8) Interagency cooperation.--
                      ``(A) In general.--In carrying out activities under
                    this section, the Homeland Security Secretary and the
                    Secretary are authorized, subject to subparagraph (B),
                    to enter into interagency agreements and other
                    collaborative undertakings with other agencies of the
                    United States Government.
                      ``(B) Limitation.--An agreement or undertaking under
                    this paragraph shall not authorize another agency to
                    exercise the authorities provided by this section to
                    the Homeland Security Secretary or to the Secretary.
              ``(9) Restrictions on use of funds.--Amounts in the special
            reserve fund under paragraph (10) shall not be used to pay--
                      ``(A) costs for the purchase of vaccines under
                    procurement contracts entered into before the date of
                    the enactment of the Project BioShield Act of 2003; or
                      ``(B) administrative costs.
              ``(10) Definitions.--
                      ``(A) Special reserve fund.--For purposes of this
                    subsection, the term `special reserve fund' has the
                    meaning given such term in section 510 of the Homeland
                    Security Act of 2002.
                      ``(B) Designated congressional committees.--For
                    purposes of this section, the term `designated
                    congressional committees' means the following
                    committees of the Congress:
                              ``(i) In the House of Representatives: the
                            Committee on Energy and Commerce, the Committee
                            on Appropriations, the Committee on Government
                            Reform, and the Select Committee on Homeland
                            Security (or any successor to the Select
                            Committee).
                              ``(ii) In the Senate: the Committee on
                            Health, Education, Labor, and Pensions, the
                            Committee on Appropriations, and the Committee
                            on Government Affairs.
      ``(d) Disclosures.--No Federal agency shall disclose under section
    552 of title 5, United States Code, any information identifying the
    location at which materials in the stockpile under subsection (a) are
    stored.
      ``(e) Definition.--For purposes of subsection (a), the term
    `stockpile' includes--
              ``(1) a physical accumulation (at one or more locations) of
            the supplies described in subsection (a); or
              ``(2) a contractual agreement between the Homeland Security
            Secretary and a vendor or vendors under which such vendor or
            vendors agree to provide to such Secretary supplies described
            in subsection (a).
      ``(f) Authorization of Appropriations.--
              ``(1) Strategic national stockpile.--For the purpose of
            carrying out subsection (a), there are authorized to be
            appropriated $640,000,000 for fiscal year 2002, and such sums
            as may be necessary for each of fiscal years 2003 through 2006.
            Such authorization is in addition to amounts in the special
            reserve fund under subsection (c)(10).
              ``(2) Smallpox vaccine development.--For the purpose of
            carrying out subsection (b), there are authorized to be
            appropriated $509,000,000 for fiscal year 2002, and such sums
            as may be necessary for each of fiscal years 2003 through
            2006.''.
      (b) Amendment to Homeland Security Act of 2002.--Title V of the
    Homeland Security Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is
    amended by adding at the end the following:

    ``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC
                        NATIONAL STOCKPILE.

      ``(a) Authorization of Appropriations.--For the procurement of
    security countermeasures under section 319F-2(c) of the Public Health
    Service Act (referred to in this section as the `security
    countermeasures program'), there is authorized to be appropriated up to
    $5,593,000,000 for the fiscal years 2004 through 2013. Of the amounts
    appropriated under the preceding sentence, not to exceed $3,418,000,000
    may be obligated during the fiscal years 2004 through 2008, of which
    not to exceed $890,000,000 may be obligated during fiscal year 2004.
      ``(b) Special Reserve Fund.--For purposes of the security
    countermeasures program, the term `special reserve fund' means the
    appropriations account established as a result of any appropriations
    made under subsection (a).
      ``(c) Availability.--
              ``(1) Integrity of special reserve fund; limitation of
            obligational authority to fund purposes; intent of congress
            against reprogramming.--Subject to paragraph (2), all amounts
            appropriated under subsection (a) are available for obligation
            through the end of fiscal year 2013 and only for the specific
            purposes set forth in the security countermeasures program. It
            is the intent of the Congress that no portion of such amount
            that remains unobligated for such purposes shall be applied,
            through reprogramming or otherwise, to any other purpose.
              ``(2) Initial availability for particular procurements.--
            Amounts appropriated under subsection (a) become available for
            a procurement under the security countermeasures program only
            upon the approval by the President of such availability for the
            procurement in accordance with paragraph (6)(B) of such
            program.
      ``(d) Related Authorizations of Appropriations.--
              ``(1) Threat assessment capabilities.--For the purpose of
            carrying out the responsibilities of the Secretary for terror
            threat assessment under the security countermeasures program,
            there are authorized to be appropriated $5,000,000 for fiscal
            year 2004, and such sums as may be necessary for each of the
            fiscal years 2005 and 2006, for the hiring of professional
            personnel within the Directorate for Information Analysis and
            Infrastructure Protection, who shall be analysts responsible
            for chemical, biological, radiological, and nuclear threat
            assessment (including but not limited to analysis of chemical,
            biological, radiological, and nuclear agents, the means by
            which such agents could be weaponized or used in a terrorist
            attack, and the capabilities, plans, and intentions of
            terrorists and other non-state actors who may have or acquire
            such agents). All such analysts shall meet the applicable
            standards and qualifications for the performance of
            intelligence activities promulgated by the Director of Central
            Intelligence pursuant to section 104 of the National Security
            Act of 1947.
              ``(2) Intelligence sharing infrastructure.--For the purpose
            of carrying out the acquisition and deployment of secure
            facilities (including information technology and physical
            infrastructure, whether mobile and temporary, or permanent)
            sufficient to permit the Secretary to receive, not later than
            December 31, 2003, all classified information and products to
            which the Under Secretary for Information Analysis and
            Infrastructure Protection is entitled under subtitle A of title
            II, there are authorized to be appropriated such sums as may be
            necessary for each of the fiscal years 2003 through 2006.
      ``(e) Emergency Development of Security Countermeasures.--If the
    Secretary of Homeland Security and the Secretary of Health and Human
    Services jointly determine that procurement of a security
    countermeasure that has been approved for procurement using the special
    reserve fund under subsection (a)--
              ``(1) is not proceeding at a sufficiently rapid pace under
            319F-2 of the Public Health Service Act to protect the national
            security; or
              ``(2) could be produced significantly less expensively by the
            government directly than through procurements under such
            section;
    then amounts in the special reserve fund may be used by the Secretary
    of Health and Human Services to produce security countermeasures for
    placement in the stockpile under subsection (a) of section 319F-2 of
    such Act if the joint determination is submitted to the President and
    the President approves such use of the special reserve fund. Amounts
    made available for such use in accordance with the preceding sentence
    are available for obligation as of the date on which the presidential
    approval is made, subject to applicable law regarding the apportionment
    of appropriations. This subsection applies notwithstanding other
    provisions of this section, and notwithstanding section 319F-2 of the
    Public Health Service Act. This subsection may not be construed as
    affecting the amounts specified in subsection (a) as authorizations of
    appropriations or the obligation limits contained therein.''.
      (c) Conforming Amendment.--Section 121 of the Public Health Security
    and Bioterrorism Preparedness and Response Act of 2002 (116 Stat. 611;
    42 U.S.C. 300hh-12) is repealed. With respect to the program
    established under former section 121 of such Act, the repeal of such
    section under the preceding sentence applies as a modification of the
    program in accordance with the amendment made by subsection (a) of this
    section, and not as the termination of the program and the
    establishment of a different program.

    SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

      Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act
    (21 U.S.C. 360bbb et seq.) is amended by adding at the end the
    following section:

    ``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

      ``(a) In General.--
              ``(1) Emergency uses.--Notwithstanding sections 505, 510(k),
            and 515 of this Act and section 351 of the Public Health
            Service Act, and subject to the provisions of this section, the
            Secretary may authorize the introduction into interstate
            commerce, during the effective period of a declaration under
            subsection (b), of a drug or device intended for use in an
            actual or potential emergency (referred to in this section as
            an `emergency use').
              ``(2) Approval status of product.--An authorization under
            paragraph (1) may authorize an emergency use of a product
            that--
                      ``(A) is not approved, licensed, or cleared for
                    commercial distribution under a provision of law
                    referred to in such paragraph (referred to in this
                    section as an `unapproved product'); or
                      ``(B) is approved, licensed, or cleared under such a
                    provision, but which use is not under such provision an
                    approved, licensed, or cleared use of the product
                    (referred to in this section as an `unapproved use of
                    an approved product').
              ``(3) Relation to other uses.--An emergency use authorized
            under paragraph (1) for a product is in addition to any other
            use that is authorized for the product under a provision of law
            referred to in such paragraph.
              ``(4) Definitions.--For purposes of this section:
                      ``(A) The term `emergency use' has the meaning
                    indicated for such term in paragraph (1).
                      ``(B) The term `product' means a drug or device.
                      ``(C) The term `unapproved product' has the meaning
                    indicated for such term in paragraph (2)(A).
                      ``(D) The term `unapproved use of an approved
                    product' has the meaning indicated for such term in
                    paragraph (2)(B).
      ``(b) Declaration of Emergency.--
              ``(1) In general.--The Secretary may declare an emergency
            justifying the authorization under this subsection for a
            product on the basis of--
                      ``(A) a determination by the Secretary of Homeland
                    Security that there is a national emergency, or a
                    significant potential for a national emergency,
                    involving a heightened risk of attack with a specified
                    biological, chemical, radiological, or nuclear agent or
                    agents;
                      ``(B) a determination by the Secretary of Defense
                    that there is a military emergency, or a significant
                    potential for a military emergency, involving a
                    heightened risk to United States military forces of
                    attack with a biological, chemical, radiological, or
                    nuclear agent or agents; or
                      ``(C) a determination by the Secretary of a public
                    health emergency under section 319 of the Public Health
                    Service Act, affecting national security and involving
                    a specified biological, chemical, radiological, or
                    nuclear agent or agents, or a specified disease or
                    condition that may be attributable to such agent or
                    agents.
              ``(2) Termination of declaration.--
                      ``(A) In general.--A declaration under this
                    subsection shall terminate upon the earlier of--
                              ``(i) a determination by the Secretary, in
                            consultation as appropriate with the Secretary
                            of Homeland Security or the Secretary of
                            Defense, that the circumstances described in
                            paragraph (1) have ceased to exist; or
                              ``(ii) the expiration of the one-year period
                            beginning on the date on which the declaration
                            is made.
                      ``(B) Renewal.--Notwithstanding subparagraph (A), the
                    Secretary may renew a declaration under this
                    subsection, and this paragraph shall apply to any such
                    renewal.
              ``(3) Advance notice of termination.--In terminating a
            declaration under this section, the Secretary shall provide
            advance notice that the declaration will be terminated. The
            period of advance notice shall be a period reasonably
            determined to provide--
                      ``(A) in the case of an unapproved product, a
                    sufficient period for disposition of shipments of the
                    product, including the return of such shipments to the
                    manufacturer (in the case of a manufacturer that
                    chooses to have the shipments returned); and
                      ``(B) in the case of unapproved uses of approved
                    products, a sufficient period for the disposition of
                    any labeling that was provided with respect to the
                    emergency use involved.
              ``(4) Publication.--The Secretary shall promptly publish in
            the Federal Register each declaration, determination, and
            renewal under this subsection.
      ``(c) Criteria for Issuance of Authorization.--The Secretary may
    issue an authorization under this section with respect to the emergency
    use of a product only if, after consultation with the Director of the
    National Institutes of Health and the Director of the Centers for
    Disease Control and Prevention, to the extent feasible and appropriate
    given the circumstances of the emergency involved, the Secretary
    concludes--
              ``(1) that an agent specified in a declaration under
            subsection (b) can cause a serious or life-threatening disease
            or condition;
              ``(2) that, based on the totality of scientific evidence
            available to the Secretary, including data from adequate and
            well-controlled clinical trials, if available, it is reasonable
            to believe that--
                      ``(A) the product may be effective in detecting,
                    diagnosing, treating, or preventing--
                              ``(i) such disease or condition; or
                              ``(ii) a serious or life-threatening disease
                            or condition caused by a product authorized
                            under this section or approved under this Act
                            or the Public Health Service Act, for
                            detecting, diagnosing, treating, or preventing
                            such a disease or condition caused by such an
                            agent; and
                      ``(B) the known and potential benefits of the
                    product, when used to detect, diagnose, prevent, or
                    treat such disease or condition, outweigh the known and
                    potential risks of the product;
              ``(3) that there is no adequate, approved, and available
            alternative to the product for detecting, diagnosing,
            preventing, or treating such disease or condition; and
              ``(4) that such other criteria as the Secretary may by
            regulation prescribe are satisfied.
      ``(d) Scope of Authorization.--
              ``(1) In general.--An authorization of a product under this
            section shall state--
                      ``(A) each disease or condition that the product may
                    be used to detect, diagnose, prevent, or treat within
                    the scope of the authorization;
                      ``(B) the Secretary's conclusions, made under
                    subsection (c)(2)(B), that the known and potential
                    benefits of the product, when used to detect, diagnose,
                    prevent, or treat such disease or condition, outweigh
                    the known and potential risks of the product; and
                      ``(C) the Secretary's conclusions, made under
                    subsection (c), concerning the safety and potential
                    effectiveness of the product in detecting, diagnosing,
                    preventing, or treating such diseases or conditions,
                    including an assessment of the available scientific
                    evidence.
              ``(2) Confidential information.--Nothing in this section
            alters or amends section 1905 of title 18, United States Code,
            or section 552(b)(4) of title 5 of such Code.
      ``(e) Conditions of Authorization.--
              ``(1) Unapproved product.--
                      ``(A) Required conditions.--With respect to the
                    emergency use of an unapproved product, the Secretary,
                    to the extent feasible given the circumstances of the
                    emergency, shall, for persons who choose to carry out
                    one or more activities for which the authorization is
                    issued, establish such conditions on an authorization
                    under this section as the Secretary finds necessary or
                    appropriate to protect the public health, including the
                    following:
                              ``(i) Appropriate conditions designed to
                            ensure that, to the extent feasible given the
                            circumstances of the emergency, health care
                            professionals administering the product are
                            informed--
                                      ``(I) that the Secretary has
                                    authorized the emergency use of the
                                    product;
                                      ``(II) of the significant known and
                                    potential benefits and risks of the
                                    emergency use of the product, and of
                                    the extent to which such benefits and
                                    risks are unknown; and
                                      ``(III) of the alternatives to the
                                    product that are available, and of
                                    their benefits and risks.
                              ``(ii) Appropriate conditions designed to
                            ensure that, to the extent feasible given the
                            circumstances of the emergency, individuals to
                            whom the product is administered are informed--
                                      ``(I) that the Secretary has
                                    authorized the emergency use of the
                                    product;
                                      ``(II) of the significant known and
                                    potential benefits and risks of such
                                    use, and of the extent to which such
                                    benefits and risks are unknown; and
                                      ``(III) of the option to accept or
                                    refuse administration of the product,
                                    of the consequences, if any, of
                                    refusing administration of the product,
                                    and of the alternatives to the product
                                    that are available and of their
                                    benefits and risks.
                              ``(iii) Appropriate conditions for the
                            monitoring and reporting of adverse events
                            associated with the emergency use of the
                            product.
                              ``(iv) For manufacturers of the product,
                            appropriate conditions concerning recordkeeping
                            and reporting, including records access by the
                            Secretary, with respect to the emergency use of
                            the product.
                      ``(B) Authority for additional conditions.--With
                    respect to the emergency use of an unapproved product,
                    the Secretary, to the extent feasible given the
                    circumstances of the emergency, may, for persons who
                    choose to carry out one or more activities for which
                    the authorization is issued, establish such conditions
                    on an authorization under this section as the Secretary
                    finds necessary or appropriate to protect the public
                    health, including the following:
                              ``(i) Appropriate conditions on which
                            entities may distribute the product with
                            respect to the emergency use of the product
                            (including limitation to distribution by
                            government entities), and on how distribution
                            is to be performed.
                              ``(ii) Appropriate conditions on who may
                            administer the product with respect to the
                            emergency use of the product, and on the
                            categories of individuals to whom, and the
                            circumstances under which, the product may be
                            administered with respect to such use.
                              ``(iii) For persons other than manufacturers
                            of the product, appropriate conditions
                            concerning recordkeeping and reporting,
                            including records access by the Secretary, with
                            respect to the emergency use of the product.
                              ``(iv) With respect to the emergency use of
                            the product, waive or limit, to the extent
                            appropriate given the circumstances of the
                            emergency, conditions regarding current good
                            manufacturing practice otherwise applicable to
                            the manufacture, processing, packing, or
                            holding of products subject to regulation under
                            this Act, including such requirements
                            established in section 501.
              ``(2) Unapproved use.--With respect to the emergency use of a
            product that is an unapproved use of an approved product:
                      ``(A) The Secretary may, for manufacturers of the
                    product who choose to carry out one or more activities
                    for which the authorization is issued, establish any of
                    the conditions described in clauses (i) through (iv) of
                    paragraph (1)(A).
                      ``(B)(i) If the authorization under this section
                    regarding the emergency use authorizes a change in the
                    labeling of the product, but the manufacturer of the
                    product chooses not to make such change, such
                    authorization may not authorize distributors of the
                    product or any other person to alter or obscure the
                    labeling provided by the manufacturer.
                      ``(ii) In the circumstances described in clause (i),
                    an authorization under this section regarding the
                    emergency use may, for persons who do not manufacture
                    the product and who choose to act under this clause,
                    authorize such persons to provide information on the
                    product in addition to the labeling provided by the
                    manufacturer, subject to compliance with clause (i).
                    Such additional information shall not be considered
                    labeling for purposes of section 502.
      ``(f) Duration of Authorization.--
              ``(1) In general.--Except as provided in paragraph (2), an
            authorization under this section shall be effective until the
            earlier of the termination of the declaration under subsection
            (b) or a revocation under subsection (g).
              ``(2) Continued use after end of effective period.--An
            authorization shall continue to be effective for continued use
            with respect to patients to whom it was administered during the
            period described by paragraph (1), to the extent found
            necessary by such patients' attending physicians.
      ``(g) Revocation of Authorization.--
              ``(1) Review.--The Secretary shall periodically review the
            circumstances and the appropriateness of an authorization under
            this section.
              ``(2) Revocation.--The Secretary may revoke an authorization
            under this section if, in the Secretary's unreviewable
            discretion, the criteria under subsection (c) for issuance of
            such authorization are no longer met.
      ``(h) Publication.--The Secretary shall promptly publish in the
    Federal Register a notice of each authorization, and each termination
    or revocation of an authorization, and an explanation of the reasons
    therefor, under this section.
      ``(i) Actions Committed to Agency Discretion.--Actions under the
    authority of this section by the Secretary, by the Secretary of
    Defense, or by the Secretary of Homeland Security are committed to
    agency discretion.
      ``(j) Rules of Construction.--Nothing in this section shall be
    construed to impair or otherwise affect--
              ``(1) the authority of the President as Commander in Chief of
            the Armed Forces of the United States under article II, section
            2 of the United States Constitution;
              ``(2) the authority of the Secretary of Defense with respect
            to the Department of Defense, including the armed forces, under
            other provisions of Federal law; or
              ``(3) the authority of the Secretary under section 319F-2 to
            manage the stockpile under such section.
      ``(k) Application to Members of Armed Forces.--
              ``(1) Waiver of requirement relating to option to refuse.--In
            the case of administration of a countermeasure to members of
            the armed forces, a requirement, under subsection
            (e)(1)(A)(ii)(III), designed to ensure that individuals are
            informed of an option to accept or refuse administration of a
            product, may be waived by the President if the President
            determines, in writing, that complying with such requirement is
            not feasible, is contrary to the best interests of the members
            affected, or is not in the interests of national security.
              ``(2) Provision of information to member of the armed
            forces.--If the Secretary makes a determination that it is not
            feasible for the information required by subsection
            (e)(1)(A)(ii) to be provided to a member of the armed forces
            prior to the administration of the product, such information
            shall be provided to such member of the armed forces (or next-
            of-kin in the case of the death of a member) to whom the
            product was administered as soon as possible, but not later
            than 30 days, after such administration. Information concerning
            the administration of the product shall be recorded in the
            medical record of the member.
              ``(3) Effect on statute pertaining to investigational new
            drugs.--In the case of an authorization based on a
            determination by the Secretary of Defense under subsection
            (b)(1)(B), section 1107 of title 10, United States Code, shall
            not apply to use of a product that is the subject of such
            authorization, within the scope of such authorization and while
            such authorization is effective.
      ``(l) Relation to Other Provisions.--If a product is the subject of
    an authorization under this section, the use of such product within the
    scope of the authorization--
              ``(1) shall not be subject to any requirements pursuant to
            section 505(i) or 520(g); and
              ``(2) shall not be subject to any requirements otherwise
            applicable to clinical investigations pursuant to other
            provisions of this Act.
      ``(m) Discretion Regarding Use of Authorization.--Nothing in this
    section provides the Secretary any authority to require any person to
    carry out any activity that becomes lawful pursuant to an authorization
    under this section, and no person is required to inform the Secretary
    that the person will not be carrying out such activity, except that a
    manufacturer of a sole-source unapproved product authorized for
    emergency use shall notify the Secretary within a reasonable period of
    time after the issuance by the Secretary of such authorization if such
    manufacturer does not intend to carry out an activity or activities
    under the authorization. This section does not have any legal effect on
    a person who does not carry out any activity for which an authorization
    under this section is issued, or who carries out such an activity
    pursuant to other provisions of this Act or section 351 of the Public
    Health Service Act.
      ``(n) Enforcement.--A person who carries out an activity pursuant to
    an authorization under this section, but who fails to comply with
    applicable conditions under subsection (e), is with respect to that act
    of noncompliance subject to the provisions of law specified in
    subsection (a) and to the enforcement of such provisions under section
    301.''.

    SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

      (a) Secretary of Health and Human Services.--
              (1) Annual reports on particular exercises of authority.--
                      (A) Relevant authorities.--The Secretary of Health
                    and Human Services (referred to in this subsection as
                    the ``Secretary'') shall submit reports in accordance
                    with subparagraph (B) regarding the exercise of
                    authority under the following provisions of law:
                              (i) With respect to section 319F-1 of the
                            Public Health Service Act (as added by section
                            2 of this Act):
                                      (I) Subsection (b)(1) (relating to
                                    increased simplified acquisition
                                    threshold).
                                      (II) Subsection (b)(2) (relating to
                                    use of noncompetitive procedures).
                                      (III) Subsection (c) (relating to
                                    expedited peer review procedures).
                              (ii) With respect to section 319F-2 of the
                            Public Health Service Act (as added by section
                            3 of this Act):
                                      (I) Subsection (c)(7)(C)(iii)
                                    (relating to simplified acquisition
                                    procedures).
                                      (II) Subsection (c)(7)(C)(iv)
                                    (relating to use of noncompetitive
                                    procedures).
                                      (III) Subsection (c)(7)(C)(v)
                                    (relating to premium provision in
                                    multiple-award contracts).
                              (iii) With respect to section 564 of the
                            Federal Food, Drug, and Cosmetic Act (as added
                            by section 4 of this Act):
                                      (I) Subsection (a)(1) (relating to
                                    emergency uses of certain drugs and
                                    devices).
                                      (II) Subsection (b)(1) (relating to a
                                    declaration of an emergency).
                                      (III) Subsection (e) (relating to
                                    conditions on authorization).
                      (B) Contents of reports.--The Secretary shall
                    annually submit to the designated congressional
                    committees (as defined in subsection (e)) a report that
                    summarizes--
                              (i) the particular actions that were taken
                            under the authorities specified in subparagraph
                            (A), including, as applicable, the
                            identification of the threat agent, emergency,
                            or the biomedical countermeasure with respect
                            to which the authority was used;
                              (ii) the reasons underlying the decision to
                            use such authorities, including, as applicable,
                            the options that were considered and rejected
                            with respect to the use of such authorities;
                              (iii) the identification of each person or
                            entity that received, or was considered and
                            rejected for, grants, cooperative agreements,
                            or contracts pursuant to the use of such
                            authorities; and
                              (iv) whether, with respect to each
                            procurement that is approved by the President
                            under section 319F-2(c)(6) of the Public Health
                            Service Act (as added by section 3 of this
                            Act), a contract was not entered into within
                            one year after such approval by the President.
              (2) Annual summaries regarding certain activity.--The
            Secretary shall annually submit to the designated congressional
            committees a report that summarizes the activity undertaken
            pursuant to the following authorities under section 319F-1 of
            the Public Health Service Act (as added by section 2 of this
            Act):
                      (A) Subsection (b)(3) (relating to increased
                    micropurchase threshold).
                      (B) Subsection (d) (relating to authority for
                    personal services contracts).
                      (C) Subsection (e) (relating to streamlined personnel
                    authority).
            With respect to subparagraph (B), the report shall include a
            provision specifying, for the one-year period for which the
            report is submitted, the number of persons who were paid
            amounts greater than $100,000 and the number of persons who
            were paid amounts between $50,000 and $100,000.
      (b) National Academy of Sciences Review.--
              (1) In general.--Not later than four years after the date of
            the enactment of this Act, the Secretary of Health and Human
            Services shall request the National Academy of Sciences to
            enter into an agreement for a review of the biomedical
            countermeasure research and development authorities established
            in this Act to determine whether and to what extent activities
            undertaken pursuant to such authorities have enhanced the
            development of biomedical countermeasures affecting national
            security, and to recommend any legislative or administrative
            changes necessary to improve the ability of the Secretary to
            carry out these activities in the future. The Secretary shall
            ensure that the results of the study are submitted to the
            designated congressional committees not later than five years
            after such date of enactment.
              (2) Certain contents.--The report under paragraph (1) shall
            include--
                      (A) a summary of the most recent analysis by the
                    Department of Homeland Security and the intelligence
                    community of the domestic threat from chemical,
                    biological, radiological, and nuclear agents;
                      (B) the Academy's assessment of the current
                    availability of countermeasures to address such
                    threats;
                      (C) the Academy's assessment of the extent to which
                    programs and activities under this Act will reduce any
                    gap between the threat and the availability of
                    countermeasures to an acceptable level of risk; and
                      (D)(i) the Academy's assessment of threats to
                    national security that are posed by technology that
                    will enable, during the 10-year period beginning on the
                    date of the enactment of this Act, the development of
                    antibiotic resistant, mutated, and bioengineered
                    strains of biological agents; and
                      (ii) recommendations on short-term and long-term
                    governmental strategies for addressing such threats,
                    including recommendations for Federal policies
                    regarding research priorities, the development of
                    countermeasures, and investments in technology.
      (c) General Accounting Office Review.--Four years after the date of
    the enactment of this Act, the Comptroller General of the United States
    shall initiate a study--
              (1)(A) to review the Secretary of Health and Human Services'
            utilization of the authorities granted under this Act with
            respect to simplified acquisition procedures, use of
            noncompetitive procedures, increased micropurchase thresholds,
            personal services contracts, streamlined personnel authority,
            and the purchase of security countermeasures under the special
            reserve fund; and
              (B) to recommend any legislative or administrative changes
            necessary to improve the utilization or effectiveness of such
            authorities in the future;
              (2)(A) to review the internal controls instituted by such
            Secretary with respect to such authorities, where required by
            this Act; and
              (B) to recommend any legislative or administrative changes
            necessary to improve the effectiveness of such controls; and
              (3)(A) to review such Secretary's utilization of the
            authority granted under this Act to authorize an emergency use
            of a biomedical countermeasure, including the means by which
            the Secretary determines whether and under what conditions any
            such authorizations should be granted and the benefits and
            adverse impacts, if any, resulting from the use of such
            authority; and
              (B) to recommend any legislative or administrative changes
            necessary to improve the utilization or effectiveness of such
            authority and to enhance protection of the public health.
    The results of the study shall be submitted to the designated
    congressional committees not later than five years after the date of
    the enactment of this Act.
      (d) Report Regarding Additional Barriers to Procurement of Security
    Countermeasures.--Not later than 180 days after the date of the
    enactment of this Act, the Secretary of Homeland Security and the
    Secretary of Health and Human Services shall report to the designated
    congressional committees any barriers to the procurement of security
    countermeasures that have not been addressed by this Act.
      (e) Status of Program for Chemical Terrorism Preparedness.--Not later
    than 180 days after the date of the enactment of this Act, the
    Secretary of Homeland Security shall submit to the designated
    congressional committees a report describing the status of the program
    carried out by the Secretary to enhance the preparedness of the United
    States to respond to terrorist attacks involving chemical agents.
      (f) Designated Congressional Committees.--For purposes of this
    section, the term ``designated congressional committees'' means the
    following committees of the Congress:
              (1) In the House of Representatives: the Committee on Energy
            and Commerce, the Committee on Appropriations, the Committee on
            Government Reform, and the Select Committee on Homeland
            Security (or any successor to the Select Committee).
              (2) In the Senate: the Committee on Health, Education, Labor,
            and Pensions, the Committee on Appropriations, and the
            Committee on Government Affairs.

    SEC. 6. OUTREACH.

      The Secretary of Health and Human Services shall develop outreach
    measures to ensure to the extent practicable that diverse institutions,
    including Historically Black Colleges and Universities and those
    serving large proportions of Hispanics, Native Americans, Asian-Pacific
    Americans, or other underrepresented populations, are meaningfully
    aware of available research and development grants and procurements
    conducted under sections 2 and 3 of this Act.

    SEC. 7. ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF
                        UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO
                        PROTECT THE HOMELAND FROM BIOLOGICAL, CHEMICAL,
                        RADIOLOGICAL, AND NUCLEAR AGENTS.

      (a) Ensuring Coordination of Programs.--The Secretary of Health and
    Human Services, the Secretary of Homeland Security, and the Secretary
    of Defense shall ensure the activities of their respective Departments
    coordinate, complement, and do not unnecessarily duplicate programs to
    identify potential domestic threats from biological, chemical,
    radiological or nuclear agents, detect such domestic incidents, analyze
    such incidents, and develop necessary countermeasures. The
    aforementioned Secretaries shall further ensure that information and
    technology possessed by the Departments relevant to these activities
    are shared with the other Departments.
      (b) Designation of Agency Coordination Officer.--The Secretary of
    Health and Human Services, the Secretary of Homeland Security, and the
    Secretary of Defense shall each designate an officer or employee of
    their respective Departments who shall coordinate, through regular
    meetings and communications, with the other aforementioned Departments
    such programs and activities carried out by their Departments.

                              Purpose and Summary

        The purpose of the Project BioShield Act of 2003 is to
    provide the Secretary of Health and Human Services with greater
    authority and flexibility to facilitate the research and
    development of biomedical countermeasures; to authorize the
    appropriation of funding for the procurement of security
    countermeasures through the creation of a special reserve fund;
    and to authorize the emergency use of unapproved drugs,
    devices, and biologics and the emergency unapproved use of
    approved drugs, devices, and biologics.

                      Background and Need for Legislation

        During times of national, military, or public health
    emergency, the American people may be placed at risk of
    exposure to biological, chemical, radiological, or nuclear
    agents, and the diseases caused by such agents. Unfortunately,
    there are not approved or available countermeasures to treat
    many diseases or conditions that may be caused by such agents.
    Currently, companies have little incentive to research,
    develop, or produce vaccines or other drugs simply for a
    possible one-time purchase by the Federal government for the
    Strategic National Stockpile. Most current private sector
    research and development dollars go for drugs or devices that
    will have continuous commercial application. In addition, some
    of the current generation of drugs or devices may have special
    uses as countermeasures to biological agents like Ebola, but
    there is little incentive to perform the research or
    development or production activities that might tailor the drug
    or drug approvals for such a purpose.
        Even if a product has been developed to treat such diseases
    or conditions, if the product has not yet been approved by the
    Food and Drug Administration (FDA), access to the therapy is
    greatly limited. Nothing in the Food and Drug Act allows the
    Secretary to suspend the approval requirements to ensure access
    to unapproved drugs and devices on a large-scale basis in times
    of emergency.
        Under present law, if a product is not approved by the FDA,
    then it is unlawful to provide that product to an individual,
    unless the product has been authorized for distribution under
    an investigational new drug (IND) application (for a drug and
    biologic) or an investigational device exemption (IDE). When a
    drug or device is available under such procedures, a number of
    conditions apply that make the use of an IND or IDE infeasible
    in times of national emergency, where drugs and devices may
    need to be deployed at rapid rates. Even if a drug, biologic,
    or device is highly promising in treating a disease or
    condition associated with biological, chemical, radiological,
    or nuclear agents, and even if it is the only therapy
    available, current FDA law does not allow for rapid deployment
    of the product.
        The Project Bioshield Act is designed to help resolve these
    problems and make our nation more secure. Like the Public
    Health Security and Bioterrorism Preparedness and Response Act,
    the Project Bioshield Act is designed to help the
    administration and the nation in public health emergency
    preparedness, but relies on the ingenuity and hard work of
    Americans in the private and public sector to achieve these
    goals.

                                    Hearings

        The Subcommittee on Emergency Preparedness and Response
    held a joint hearing with the Subcommittee on Health of the
    Committee on Energy and Commerce on ``Furthering Public Health
    Security: Project Bioshield'' on March 27, 2003. The
    Subcommittee received testimony from: The Honorable Tommy
    Thompson, Secretary, U.S. Department of Health and Human
    Services; Mr. Leighton Read M.D., General Partner, Alloy
    Ventures, on behalf of Biotechnology Industry Organization; Mr.
    Michael Friedman M.D., Chief Medical Officer for Biomedical
    Preparedness, PhRMA; Mr. James Baker Jr., Ruth Dow Doan
    Professor, Center for Biological Nanotechnology; and, Mr. Gary
    Noble M.D., Vice President of Medical and Public Affairs,
    Johnson & Johnson, on behalf of AdvaMed.
        The Full Committee held a hearing on ``Bioshield:
    Countering the Bioterrorist Threat'' on May 15, 2003. The
    Committee received testimony from: Dr. Anthony Fauci, Director,
    National Institute of Allergy and Infectious Diseases; Dr. L.
    Garry Adams, Associate Dean for Research, Biodefense &
    Infectious Diseases, College of Veterinary Medicine, Texas A&M
    University; Dr. Clarence James Peters, Director for Biodefense,
    Center for Biodefense and Emerging Infectious Diseases,
    University of Texas Medical Branch; Dr. Ronald Crystal,
    Professor and Chairman, Department of Genetic Medicine, Weill
    Medical College of Cornell University; William A. Haseltine,
    Ph.D., Chairman and Chief Executive Officer, Human Genome
    Sciences, Inc.; Alan Pemberton, Pharmaceutical Research and
    Manufacturers of America; Robert J. Sutcliffe, Director,
    President and Chief Executive Officer, Digital Gene
    Technologies, Inc.; and, Frank M. Rapoport, Partner, McKenna
    Long & Aldridge LLP.
        The Subcommittee on Emergency Preparedness and Response and
    The Subcommittee on Intelligence and Counterterrorism held a
    joint hearing on ``Does the Homeland Security Act of 2002 give
    the Department the Tools it Needs to Determine Which Bio-
    Warfare Threats are Most Serious?'' on June 5, 2003. The
    Committee received testimony from: Paul J. Redmond, Assistant
    Secretary, Information Analysis, Department of Homeland
    Security; and, Eric Tolbert, Director of the Response Division,
    Emergency Preparedness and Response Directorate, Department of
    Homeland Security.
        The Full Committee held a hearing on ``Bioshield: Lessons
    from Current Efforts to Develop Bio-Warfare Countermeasures''
    on June 6, 2003. The Committee received testimony from: Dr.
    John Ring La Montagne, Deputy Director, National Institute of
    Allergy and Infectious Diseases, National Institutes of Health,
    Department of Health and Human Services; and, Dr. Ali Khan,
    Chief Science Officer, Parasitic Diseases, National Center for
    Infectious Diseases, Center for Disease Control and Prevention,
    Department of Health and Human Services.

                            Committee Consideration

        On Thursday, June 27, 2003, the Full Committee met in open
    markup session and ordered H.R. 2122 reported to the House, as
    amended, by a record vote of 29 yeas and 0 nays.

                                Committee Votes

        Clause 3(b) of rule XIII of the Rules of the House of
    Representatives requires the Committee to list the record votes
    on the motion to report legislation and amendments thereto.
        H.R. 2122, to enhance research, development, procurement,
    and use of biomedical countermeasures to respond to public
    health threats affecting national security, and for other
    purposes; was ordered favorably reported to the House, amended,
    by a recorded vote of 29 yeas and 0 nays (Roll Call Vote No. 4)
    as follows:

        The following amendments were offered:
        An Amendment in the Nature of a Substitute offered by Mr.
    Cox (#1), was AGREED TO by voice vote, as amended.
        An amendment offered by Mr. Hunter to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1A), Page 17,
    beginning on line 23, strike ``Homeland Security Secretary''
    and insert ``Homeland Security Secretary, Secretary of Defense
    and Secretary of State.'' was AGREED TO by a recorded vote of
    25 yeas and 0 nays (Roll Call Vote No. 1) as follows:

        An amendment offered by Mr. Hunter to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1B), Page 52, line
    24, insert a new section entitled ``Ensuring coordination,
    cooperation and the elimination of unnecessary duplication in
    programs designed to protect the homeland from biological,
    chemical, radiological, and nuclear agents'' was AGREED TO by
    voice vote.
        An amendment offered by Mr. DeFazio to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1C), to insert a
    new subsection entitled ``Status of Program for Chemical
    Terrorism Preparedness'' was AGREED TO by voice vote.
        An amendment offered by Ms. Slaughter to the Amendment in
    the Nature of a Substitute offered by Mr. Cox (#1D), to insert
    a new section entitled ``Expatriate Corporations'' was NOT
    AGREED TO by a recorded vote of 17 yeas and 18 nays (Roll Call
    Vote No. 2) as follows:

        An amendment offered by Mr. Markey to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1E), Page 37, line
    9, add the following: ``If an authorization under the preceding
    sentence for a product is revoked under subsection (g), or if
    the declaration of an emergency under subsection (b) ceases to
    be in effect, the product may not be introduced into interstate
    commerce except in accordance with section 505, 510(k), or 515,
    or section 351 of the Public Health Service Act, as
    applicable.'' was WITHDRAWN.
        An amendment offered by Ms. Jackson-Lee to the Amendment in
    the Nature of a Substitute offered by Mr. Cox (#1F), to insert
    a new section at the end of the bill entitled ``Sec. 6.
    Inclusion of Certain Populations in Research, Development, and
    Procurement Projects.'' was WITHDRAWN.
        An amendment offered by Mr. Tauzin to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1G), Page 28,
    strike line 16 and all that follows through page 29, line 19
    was NOT AGREED TO by a recorded vote of 19 yeas and 19 nays
    (Roll Call Vote No. 3). As follows:

        An amendment offered by Mr. Andrews to the Amendment in the
    Nature of a Substitute offered by Mr. Cox (#1H), on page 16,
    line 4 of the Cox-Turner Substitute amendment: add the
    following: ``notwithstanding the preceding provisions of this
    subclause, nothing in this section shall alter the rights of
    the parties afforded by the Federal Acquisition Regulation or
    other applicable laws or regulations regarding a termination
    for the convenience of the government.'' was WITHDRAWN.
        An amendment offered by Ms. Jackson-Lee to the Amendment in
    the Nature of a Substitute offered by Mr. Cox (#1I), to insert
    at the end of the substitute the following section: ``Sec. 6.
    Outreach.'' was AGREED TO by voice vote.

                          Committee Oversight Findings

        Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
    House of Representatives, the Committee has held oversight
    hearings and made findings that are reflected in this report.

             Statement of General Performance Goals and Objectives

        The purpose of the Project BioShield Act of 2003 is to
    provide the Secretary of Health and Human Services and the
    Secretary of Homeland Security greater authority and
    flexibility to facilitate the research, development, and
    procurement of biomedical countermeasures.

       New Budget Authority, Entitlement Authority, and Tax Expenditures

        In compliance with clause 3(c)(2) of rule XIII of the Rules
    of the House of Representatives, the Committee finds that H.R.
    2122, the Project Bioshield Act of 2003, would result in no new
    or increased budget authority, entitlement authority, or tax
    expenditures or revenues.

                      Congressional Budget Office Estimate

        Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
    House of Representatives, a cost estimate provided by the
    Congressional Budget Office pursuant to section 402 of the
    Congressional Budget Act of 1974 was not made available to the
    Committee in time for the filing of this report. The Chairman
    of the Committee shall cause such estimate to be printed in the
    Congressional Record upon its receipt by the Committee.

                           Federal Mandates Statement

        An estimate of Federal mandates prepared by the Director of
    the Congressional Budget Office pursuant to section 423 of the
    Unfunded Mandates Reform Act was not made available to the
    Committee in time for the filing of this report. The Chairman
    of the Committee shall cause such estimate to be printed in the
    Congressional Record upon its receipt by the Committee.

                          Advisory Committee Statement

        No advisory committees within the meaning of section 5(b)
    of the Federal Advisory Committee Act were created by this
    legislation.

                       Constitutional Authority Statement

        Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
    House of Representatives, the Committee finds that the
    Constitutional authority for this legislation is provided in
    Article I, section 8, clause 1, which grants Congress the power
    to provide for the common Defense of the United States.

                      Applicability to Legislative Branch

        The Committee finds that the legislation does not relate to
    the terms and conditions of employment or access to public
    services or accommodations within the meaning of section
    102(b)(3) of the Congressional Accountability Act.

                 Section-by-Section Analysis of the Legislation

    Section 1. Short title

        Section 1 establishes the short title of the Act as the
    ``Project BioShield Act of 2003.''

    Section 2. Biomedical countermeasure research and development
            authorities

        Section 2(a) of the Project BioShield Act of 2003 amends
    the Public Health Service Act to add a new section 319F-1. The
    section grants the Secretary of the Department of Health and
    Human Services (HHS) additional flexibility and authority in
    conducting research and development with respect to biomedical
    countermeasures against biological, chemical, nuclear and
    radiological agents that may affect national security.
        New subsection 319F-1(a) provides general authority.
    Proposed subparagraph 319F-1(a)(4) makes the facilities of
    entities that enter into a grant or cooperative agreement with
    the Secretary of HHS under this section available as needed to
    such Secretary of HHS to respond to public health emergencies
    affecting national security.
        New subsection 319F-1(b) provides expedited authority for
    governmental procurements used to perform, administer, or
    support pressing research and development activities under this
    section, by (1) increasing the simplified acquisition threshold
    from $100,000 to $25 million; (2) authorizing the use of
    procedures providing for less than full and open competition
    when there are only a limited number of responsible sources and
    no other type of services will satisfy the Secretary of HHS
    needs; and (3) increasing the micropurchase threshold for such
    procurements to $15,000.
        New subsection 319F-1(c) authorizes the Secretary of HHS to
    use expedited peer-review procedures in lieu of otherwise
    applicable peer-review procedures in the case of grants and
    contracts for biomedical countermeasure research and
    development activity, if such grants and contracts do not
    exceed $1,500,000 and are necessary to respond to pressing
    research needs.
        New subsection 319F-1(d) provides additional flexibility to
    the Secretary of HHS with respect to the hiring of experts and
    consultants when necessary to respond to pressing qualified
    countermeasure research and development needs. Under paragraph
    319F-1(d)(2), such experts and consultants are deemed to be
    employees of HHS for purposes of the Federal Torts Claims Act,
    which provides the exclusive remedy against such personnel for
    claims relating to the performance of covered duties.
        New subsection 319F-1(e) provides streamlined personnel
    authority for the Secretary of HHS to appoint up to 30 people
    to positions in the National Institutes of Health without
    regard to ordinary classification criteria, when necessary to
    respond to pressing qualified countermeasure research and
    development needs.
        New subsection 319F-1(f) provides that actions by the
    Secretary of HHS under the section are committed to agency
    discretion.
        Section 2(b) of the Project BioShield Act of 2003 amends
    section 481A of the Public Health Service Act to add the
    Director of the National Institute of Allergy and Infectious
    Diseases to that section, and thus provide to that Director
    certain authorities concerning modernization and construction
    of research facilities. Section 2(b) further authorizes such
    sums as may be necessary for such purposes.

    Section 3. Biomedical countermeasures procurement

        Section 3(a) of the Project BioShield Act of 2003 adds a
    new section 319F-2 to the Public Health Service Act. Several
    provisions of new section 319F-2 simply transfer existing
    provisions of law from the Public Health Security and
    Bioterrorism Preparedness and Response Act of 2002, as amended
    by the Homeland Security Act of 2002. Proposed Subsection 319F-
    2(a) contains language from existing law establishing the
    Strategic National Stockpile. New section 319F-2(b) contains
    language from existing law concerning authorizing procurement
    of smallpox vaccine for the National Strategic Stockpile.
        New section 319F-2(c) requires the Secretary of the
    Department of Homeland Security (DHS) to assess threats that
    may be posed by chemical, biological, radiological, and nuclear
    agents, and requires the HHS Secretary to assess the public
    health consequences of such agents and the availability and
    appropriateness of countermeasures for the threats identified.
    After these steps, the Secretaries jointly may determine and
    recommend to the President that funding for procurement of such
    a countermeasure for the nation's stockpile is appropriate from
    the special reserve fund established by this Act.
        Under section 319F-2(c)(4), the Secretaries of HHS and DHS
    may recommend to the President a proposal to issue a call for
    the development of countermeasures. Such a call includes a
    commitment from the Secretaries to make a recommendation for
    funding procurement of such a countermeasure from the special
    reserve fund, if government specifications for the product are
    achieved. The Secretaries also may secure a Presidential
    approval for funding prior to, or without, conducting a call.
        New section 319F-2(c)(4)(B) provides that the Secretaries
    should include in any call for proposals for countermeasure
    production information that may be necessary to encourage or
    facilitate research and development into such countermeasures.
    The Committee recognizes that an important factor companies
    will consider in determining whether to invest scarce research
    and development dollars into security countermeasures is
    whether and to what extent they may face liability relating to
    the development or production of such countermeasures. The
    Committee thus encourages the Secretaries to indicate in any
    call for proposals the potential availability of
    indemnification or liability protections under other laws. The
    Secretary of Homeland Security is further encouraged to
    designate such countermeasures as ``qualified anti-terrorism
    technologies'' as defined in section 862 of the Homeland
    Security Act.
        Under section 319F-2(c)(7), if the President approves a
    recommendation for funding from the special reserve fund, DHS
    would then enter into an agreement with HHS under which HHS may
    procure the countermeasure for the stockpile using the DHS
    special reserve fund. Contracts under this paragraph are
    subject to certain conditions, including the condition that
    payment shall only be made upon ``substantial delivery,''
    unless the Secretary of HHS determines an advance of up to 10
    percent of the contract amount is necessary to ensure success
    of the project. This provision does not alter the rights of
    contracting parties under the Federal Acquisition Regulation or
    other applicable laws or regulations regarding a termination
    for the convenience of the government. The Secretary of HHS is
    authorized to include contract provisions limiting or
    forbidding non-stockpile sales of a security countermeasure.
    The Secretary is strongly encouraged to include such provisions
    when it is necessary or desirable in order to protect United
    States national security interests with respect to the transfer
    of highly specialized countermeasures or enabling intellectual
    property, and particularly to guard against the transfer of
    such countermeasures or intellectual property to specific
    foreign entities when the Secretary, in consultation with the
    Secretaries of the Departments of Homeland Security, State, and
    Defense, believes that the transfer would have undesirable
    national security implications or pose an unacceptable risk to
    the national security.
        Section 319F-2(d) contains prohibitions on disclosure of
    information transferred from existing law. Section 319F-2(e)
    contains definitions transferred from existing law.
        Section 319F-2(f) contains authorization of appropriations
    for the Strategic National Stockpile and smallpox vaccine
    development transferred from existing law with one addition.
    The new paragraph makes clear that such existing authorizations
    are in addition to amounts authorized under the special reserve
    fund. Nothing in the Act would restrict or alter the
    Secretaries' existing authority to purchase items for the
    stockpile using existing discretionary appropriations for such
    purpose.
        Section 3(b) of the Project BioShield Act of 2003 adds a
    new section 510 to the Homeland Security Act of 2002. This new
    section authorizes appropriations for the special reserve fund
    referenced in the new section 319F-2(c) of the Public Health
    Service Act. The bill authorizes $890 million in FY 04 for such
    procurements, and aggregate amounts of $3.4 billion and $5.6
    billion over the next five and ten fiscal years respectively.
    All amounts appropriated under this authorization would be
    available for obligation through the end of FY 2013.
        The new section 510 of the Homeland Security Act also
    authorizes $5 million in FY 04 for the hiring of professional
    biological, chemical, radiological, and nuclear threat analysts
    at DHS, and such sums as are necessary to construct secure
    facilities for the receipt of classifiedinformation necessary
    to allow the Secretary of DHS to carry out his threat assessment
    responsibilities under this Act. The Committee expects that the
    Secretary of DHS will receive the full cooperation of other agencies in
    the federal government in getting up-to-date intelligence and other
    information, as required by the Homeland Security Act.
        Subsection 510(e) allows the Secretaries of DHS and HHS to
    use the special reserve fund to produce security
    countermeasures directly, if they jointly determine, and the
    President approves, that procurement is not proceeding rapidly
    enough.
        The Act defines the scope of the new authorities set forth
    in this section as applying to countermeasures against agents
    that the Secretary of DHS believes present ``a material threat
    against the United States population'' and about which the HHS
    and DHS Secretaries make certain additional findings. The
    Committee expects that both Secretaries will consider the
    threat of use of such agents by terrorists against the U.S.
    population to be a significant factor in making their
    respective scope determinations under these provisions.
    However, the Committee also recognizes and encourages the
    Secretaries to consider the emerging threats to public health
    and national security that may be caused by the spread of
    antibiotic resistant organisms or dangerous viruses that may
    spread rapidly and lack effective countermeasures today. These
    threats may affect national security whether by terrorists or
    through natural conditions. The Secretaries should consider
    such factors in determining whether to use these new
    authorities to promote research, development, and production of
    security countermeasures, such as broad-spectrum antibiotics,
    that could be useful against a range of potential threat
    agents.

    Section 4. Authorization for medical products for use in emergencies

        Section 4 adds a new section 564 to the Federal Food, Drug,
    and Cosmetic Act. New section 564(a) allows the Secretary of
    Health and Human Services to authorize for introduction into
    interstate commerce unapproved drugs, devices, and biological
    products or unapproved uses of approved drugs, approved/cleared
    devices, and biological products intended for use in an actual
    or potential emergency during the effective period of a
    declaration.
        New section 564(b) allows the Secretary of HHS to declare
    an emergency justifying an emergency use authorization based
    upon a determination by the Secretary of Homeland Security that
    there is a national emergency or the significant potential of
    one, or by a determination of the Secretary of Defense that
    there is a military emergency, or a significant potential of
    one. Such emergencies must involve a heightened risk of attack
    with biological, chemical, radiological, or nuclear agents.
    Similarly, an emergency use authorization can be based upon a
    determination of the Secretary of HHS that there is a public
    health emergency affecting national security and involving
    biological, chemical, radiological, or nuclear agents. In
    making a determination about whether a public health emergency
    under section 319 of the Public Health Service Act affects
    national security, the Secretary may consider all information
    he deems pertinent and appropriate, and nothing in this Act
    requires that the Secretary consult with other executive branch
    officials prior to making such a determination.
        Under this section, any declaration of emergency will last
    for one year, unless the Secretary of HHS terminates it at an
    earlier time. The Secretary of HHS may renew a declaration. The
    Secretary of HHS must publish all declarations, determinations,
    and renewals in the Federal Register, and the Secretary must
    provide reasonable advanced notice that declarations are to be
    terminated under this section. The Committee intends that,
    after a declaration is terminated, final disposition of
    labeling or intrastate disposition of a product may occur.
    Further, the Committee believes that the Commissioner of the
    Food and Drug Administration (Commissioner) may exercise
    enforcement discretion not to object to interstate shipment of
    an unapproved product for return to a manufacturer. A
    determination of what is a ``reasonable'' period for advanced
    notice of termination should consider all factors, so in some
    cases notice immediately preceding termination may be
    reasonable, while in other circumstances it may not.
        Section 564(c) details the criteria for issuance of an
    emergency use authorization. Under this new section, the
    Secretary of HHS, acting through the Commissioner, may issue an
    authorization upon concluding (1) that a biological, chemical,
    radiological, or nuclear agent or agents can cause a serious or
    life-threatening disease or condition; (2) that the drug,
    device or biological product may be effective in detecting,
    diagnosing, treating, or preventing such disease or condition
    (or a serious disease or condition caused by taking a product
    already approved, licensed or cleared by FDA for treating or
    preventing such disease or condition), and the benefits of the
    product outweigh risks; (3) that there is no adequate,
    approved, and available alternative to the product; and, (4)
    other criteria the Secretary may by regulation specify. The
    Commissioner should consult with the Directors of the National
    Institutes of Health and the Centers for Disease Control and
    Prevention prior to issuing an authorization, but such
    consultation is limited by considerations of feasibility and
    appropriateness given the circumstances of the emergency.
        Section 564(d) concerns the scope of an emergency use
    authorization. Under this section, the authorization shall
    state the disease or condition that the product may be used to
    detect, diagnose, prevent, or treat, as well as the
    Commissioner's conclusions about known benefits and risks of
    the product and conclusions concerning safety and potential
    effectiveness. The Committee intends that before issuing an
    authorization under this section, the Commissioner will, where
    feasible given the nature and the extent of the emergency,
    notify the holder of any relevant application under this
    chapter or under section 351 of the Public Health Service Act.
    The purpose of such notification is to allow for discussion of
    the conditions of this authorization as required by subsection
    (e), as well as discussion of whether such product should be
    delivered pursuant to section 319F-2(c) of the Public Health
    Service Act.
        Section 564(e) pertains to products that have never been
    approved, licensed, or cleared by FDA. Under this subsection,
    conditions shall, to the extent feasible given the
    circumstances of the emergency, be applied to persons who
    choose to carry out an activity for which the authorization is
    issued. Such mandatory conditions include information to
    providers about the emergency use of the product as well as
    significant known potential risks and benefits, as well as
    appropriate conditions designed to ensure that to the maximum
    extent feasible given the circumstances of the emergency,
    individuals to whom the product is administered are informed of
    the emergency use of the product, risks and benefits of the
    product, and of the option to accept or refuse the product.
    Further, the Commissioner is given the authority to impose
    other conditions on those who carry out activities for which
    the authorization is issued. Such conditions imposed by the
    Commissioner should be designed to provide maximum flexibility
    to ensure that those who wish to take the product can indeed
    take the product, if made available by the manufacturer.
        Section 564(e) also applies to unapproved uses of approved
    products and the Commissioner may, for manufacturers who choose
    to carry out one or more activities pursuant to an emergency
    use authorization, apply certain conditions. This subsection
    makes clear that manufacturers do not have to avail themselves
    of the emergency use authorization for unapproved uses of
    approved products, and it makes clear that no individual may
    alter or obscure the labeling ofalready approved products. It
    does authorize, however, persons other than the manufacturer to provide
    information about the product concerning the emergency use of the
    product.
        Under section 564(e), the Commissioner may establish
    conditions regarding product labeling and information
    conveyance concerning unapproved products. Further, the
    Committee intends that the Commissioner may establish
    conditions regarding product labeling and information
    conveyance on manufacturers that carry out one or more
    activities pursuant to an emergency use authorization with
    respect to the emergency use of that product that is an
    unapproved use of an approved product.
        Subsection (f) makes clear that an emergency use
    authorization is effective until the declaration is terminated
    or revoked, but allows patients to continue using such products
    in certain instances. Nothing in this subsection is intended to
    require manufacturers or others to provide such products to
    patients.
        Subsection (g) makes clear that the Commissioner shall
    periodically review the appropriateness of an authorization,
    and it provides the Commissioner needed flexibility to revoke
    an authorization if the criteria justifying the authorization
    are no longer met.
        Subsection (h) ensures that the Commissioner shall promptly
    publish in the Federal Register notices of all authorizations,
    terminations, and revocations. Subsection (i) makes clear that
    all determinations under this new section are committed to
    agency discretion. Subsection (j) is a rule of construction
    noting that this new section does not impair or otherwise
    affect certain existing authorities.
        New section 564(k) pertains to members of the Armed Forces
    and, among other things, it specifies that the President may
    waive requirements designed to ensure that such members are
    informed of the option to accept or refuse administration of an
    emergency use product, upon certain findings (which are
    identical to the findings found in section 1107 of Title 10).
    Further, the subsection requires that if certain information is
    not provided to members of the Armed Forces prior to an
    emergency use product being administered to them, then
    information concerning the administration of the product shall
    be placed in the medical record of the member.
        Subsection (l) makes clear that if a product is authorized
    for emergency use under this new section, the investigational
    sections of the Act shall not apply to the products.
        Subsection (m) ensures that no authority in new section 564
    can require a manufacturer of a drug, device, or biological
    product to perform any activity that becomes lawful pursuant to
    the new section. That is, the Commissioner in no way is given
    the authority to, among other things, require a manufacturer to
    introduce into interstate commerce or deliver for introduction
    into interstate commerce any unapproved product or an approved
    product for an unapproved use under this section. Further, even
    if the Commissioner authorizes the emergency use of an already-
    approved, licensed or cleared product, a manufacturer can
    refuse to avail themselves of such emergency use authorization
    and continue introducing into interstate commerce its approved
    or cleared product under the Federal Food, Drug and Cosmetic
    Act, or licensed product pursuant to the Public Health Service
    Act. The only obligation in subsection (m) is that if the
    Commissioner authorizes the emergency use of a sole-source
    unapproved product, then the manufacturer of such product must
    inform the Commissioner of its intention not to carry out any
    activity under the authorization within a reasonable period of
    time. Nothing in this section shall be construed as authorizing
    the Commissioner to establish conditions on the distribution,
    administration, or labeling of any other product in any other
    circumstance.
        Subsection (n) ensures that the present enforcement regime
    of the Federal Food, Drug, and Cosmetic Act will apply to
    individuals who carry out an activity or activities pursuant to
    an authorization, but fail to comply with applicable
    conditions. If any person carries out an activity pursuant to
    section 564, but violates a condition imposed by the
    Commissioner, then that person will be subject to Chapter III
    of the Act, where the ``prohibited acts'' are found. If a
    person is found to be in violation of a prohibited act found in
    section 301, then the Committee intends for that person to be
    subject to the enforcement provisions found in sections 302,
    303, and 304. A violation of any condition applied to an
    emergency use product in no way alters or affects the emergency
    use status of the underlying product.

    Section 5. Reports

        Section 5(a) requires the Secretary of HHS to submit annual
    reports to Congress concerning the exercise of many of the new
    authorities under the Act. Section 5(b) requires a report from
    the National Academy of Sciences concerning whether and to what
    extent the research authorities granted under the Act have
    enhanced the development of biomedical countermeasures
    affecting national security. Section 5(c) requires the General
    Accounting Office to issue a report concerning the Secretary of
    HHS utilization of these new authorities. Section 5(d) requires
    the Secretaries of HHS and DHS to report any additional
    barriers to procurement of security countermeasures which have
    not been addressed by Bioshield. The Secretaries should include
    in this report information as to whether there is a shortage of
    adequate biocontainment facilities or other resources for
    carrying out necessary research and development and testing.
    Section 5(e) requires the Secretary of DHS to report on the
    status of chemical preparedness.

    Section 6. Ensuring coordination, cooperation and the elimination of
            unnecessary duplication in programs designed to protect the
            homeland from biological, chemical, radiological, and nuclear
            agents

        Section 6 requires the Secretaries of the HHS, DHS, and DOD
    to coordinate their efforts to identify and develop
    countermeasures to biological, chemical, radiological, and
    nuclear threats. These Departments are instructed to designate
    agency coordination officers for this purpose.

    Section 7. Outreach

        Section 7 instructs the Secretary of HHS to ensure that, to
    the extent practicable, Historically Black Colleges and
    Universities and other minority research institutions are made
    aware of research and development grants and procurements under
    Bioshield.

             Changes in Existing Law Made by the Bill, as Reported

      In compliance with clause 3(e) of rule XIII of the Rules of
    the House of Representatives, changes in existing law made by
    the bill, as reported, are shown as follows (existing law
    proposed to be omitted is enclosed in black brackets, new
    matter is printed in italics, existing law in which no change
    is proposed is shown in roman):

    PUBLIC HEALTH SERVICE ACT

               *       *       *       *       *       *       *

    TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

               *       *       *       *       *       *       *

    Part B--Federal-State Cooperation

               *       *       *       *       *       *       *

    SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING
                        BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT
                        ACTIVITIES.

      (a) In General.--
              (1) Authority.--In conducting and supporting research
            and development activities regarding biomedical
            countermeasures under section 319F(h), the Secretary
            may conduct and support such activities in accordance
            with this section if the activities concern qualified
            countermeasures.
              (2) Qualified countermeasure.--For purposes of this
            section, the term ``qualified countermeasure'' means a
            priority countermeasure (as defined in section 319F(h))
            that affects national security.
              (3) Interagency cooperation.--
                      (A) In general.--In carrying out activities
                    under this section, the Secretary is
                    authorized, subject to subparagraph (B), to
                    enter into interagency agreements and other
                    collaborative undertakings with other agencies
                    of the United States Government.
                      (B) Limitation.--An agreement or undertaking
                    under this paragraph shall not authorize
                    another agency to exercise the authorities
                    provided by this section.
              (4) Availability of facilities to the secretary.--In
            any grant or cooperative agreement entered into under
            the authority provided in this section with respect to
            a biocontainment laboratory or other related or
            ancillary specialized research facility that the
            Secretary determines necessary for the purpose of
            performing, administering, and supporting qualified
            countermeasure research and development, the Secretary
            may provide that the facility that is the object of
            such grant or cooperative agreement shall be available
            as needed to the Secretary to respond to public health
            emergencies affecting national security.
      (b) Expedited Procurement Authority.--
              (1) Increased simplified acquisition threshold for
            biomedical countermeasure procurements.--
                      (A) In general.--For any procurement by the
                    Secretary of property or services for use (as
                    determined by the Secretary) in performing,
                    administering, or supporting qualified
                    countermeasure research or development
                    activities under this section that the
                    Secretary determines necessary to respond to
                    pressing research and development needs under
                    this section, the amount specified in section
                    4(11) of the Office of Federal Procurement
                    Policy Act (41 U.S.C. 403(11)), as applicable
                    pursuant to section 302A(a) of the Federal
                    Property and Administrative Services Act of
                    1949 (41 U.S.C. 252a(a)), shall be deemed to be
                    $25,000,000 in the administration, with respect
                    to such procurement, of--
                              (i) section 303(g)(1)(A) of the
                            Federal Property and Administrative
                            Services Act of 1949 (41 U.S.C.
                            253(g)(1)(A)) and its implementing
                            regulations; and
                              (ii) section 302A(b) of such Act (41
                            U.S.C. 252a(b)) and its implementing
                            regulations.
                      (B) Application of certain provisions.--
                    Notwithstanding subparagraph (A) and the
                    provision of law and regulations referred to in
                    such subparagraph, each of the following
                    provisions shall apply to procurements
                    described in this paragraph to the same extent
                    that such provisions would apply to such
                    procurements in the absence of subparagraph
                    (A):
                              (i) Chapter 37 of title 40, United
                            States Code (relating to contract work
                            hours and safety standards).
                              (ii) Subsections (a) and (b) of
                            Section 7 of the Anti-Kickback Act of
                            1986 (41 U.S.C. 57(a) and (b)).
                              (iii) Section 304C of the Federal
                            Property and Administrative Services
                            Act of 1949 (41 U.S.C. 254d) (relating
                            to the --- examination of contractor
                            records).
                      (C) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal
                    controls for procurements that are under this
                    paragraph, including requirements with regard
                    to documenting the justification for use of the
                    authority in this paragraph.
              (2) Use of noncompetitive procedures.--In addition to
            any other authority to use procedures other than
            competitive procedures, the Secretary may use such
            other procedures when--
                      (A) the procurement is as described by
                    paragraph (1); and
                      (B) the property or services needed by the
                    Secretary are available from only one
                    responsible source or only from a limited
                    number of responsible sources, and no other
                    type of property or services will satisfy the
                    Secretary's needs.
              (3) Increased micropurchase threshold.--
                      (A) In general.--For a procurement described
                    by paragraph (1), the amount specified in
                    subsections (c), (d), and (f) of section 32 of
                    the Office of Federal Procurement Policy Act
                    (41 U.S.C. 428) shall be deemed to be $15,000
                    in the administration of that section with
                    respect to such procurement.
                      (B) Internal controls to be instituted.--The
                    Secretary shall institute appropriate internal
                    controls for purchases that are under this
                    paragraph and that are greater than $2,500.
                      (C) Exception to preference for purchase card
                    mechanism.--No provision of law establishing a
                    preference for using a Government purchase card
                    method for purchases shall apply to purchases
                    that are under this paragraph and that are
                    greater than $2,500.
      (c) Authority To Expedite Peer Review.--
              (1) In general.--The Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under
            this section, employ such expedited peer review
            procedures (including consultation with appropriate
            scientific experts) as the Secretary, in consultation
            with the Director of NIH, deems appropriate to obtain
            assessment of scientific and technical merit and likely
            contribution to the field of qualified countermeasure
            research, in place of the peer review and advisory
            council review procedures that would be required under
            sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
            406(a)(3)(A), 492, and 494, as applicable to a grant,
            contract, or cooperative agreement--
                      (A) that is for performing, administering, or
                    supporting qualified countermeasure research
                    and development activities; and
                      (B) the amount of which is not greater than
                    $1,500,000.
              (2) Subsequent phases of research.--The Secretary's
            determination of whether to employ expedited peer
            review with respect to subsequent phases of a research
            grant or cooperative agreement under this section shall
            be determined without regard to the peer review
            procedures used for any prior peer review of that same
            grant or cooperative agreement.
      (d) Authority for Personal Services Contracts.--
              (1) In general.--For the purpose of performing,
            administering, and supporting qualified countermeasure
            research and development activities, the Secretary may,
            as the Secretary determines necessary to respond to
            pressing qualified countermeasure research and
            development needs under this section, obtain by
            contract (in accordance with section 3109 of title 5,
            United States Code, but without regard to the
            limitations in such section on the period of service
            and on pay) the personal services of experts or
            consultants who have scientific or other professional
            qualifications, except that in no case shall the
            compensation provided to any such expert or consultant
            exceed the daily equivalent of the annual rate of
            compensation for the President.
              (2) Federal tort claims act coverage.--
                      (A) In general.--A person carrying out a
                    contract under paragraph (1), and an officer,
                    employee, or governing board member of such
                    person, shall be deemed to be an employee of
                    the Department of Health and Human Services for
                    purposes of claims under sections 1346(b) and
                    2672 of title 28, United States Code, for money
                    damages for personal injury, including death,
                    resulting from performance of functions under
                    such contract.
                      (B) Exclusivity of remedy.--The remedy
                    provided by subparagraph (A) shall be exclusive
                    of any other civil action or proceeding by
                    reason of the same subject matter against the
                    person, officer, employee, or governing board
                    member.
              (3) Internal controls to be instituted.--
                      (A) In general.--The Secretary shall
                    institute appropriate internal controls for
                    contracts under this subsection, including
                    procedures for the Secretary to make a
                    determination of whether a person, or an
                    officer, employee, or governing board member of
                    a person, is deemed to be an employee of the
                    Department of Health and Human Services
                    pursuant to paragraph (2).
                      (B) Determination of employee status to be
                    final.--A determination by the Secretary under
                    subparagraph (A) that a person, or an officer,
                    employee, or governing board member of a
                    person, is or is not deemed to be an employee
                    of the Department of Health and Human Services
                    shall be final and binding on the Secretary and
                    the Attorney General and other parties to any
                    civil action or proceeding.
              (4) Number of personal services contracts limited.--
            The number of experts and consultants whose personal
            services are obtained under paragraph (1) shall not
            exceed 30 at any time.
      (e) Streamlined Personnel Authority.--
              (1) In general.--In addition to any other personnel
            authorities, the Secretary may, as the Secretary
            determines necessary to respond to pressing qualified
            countermeasure research and development needs under
            this section, without regard to such provisions of
            title 5, United States Code, governing appointments in
            the competitive service, and without regard to the
            provisions of chapter 51 and subchapter III of chapter
            53 of such title relating to classification and General
            Schedule pay rates, appoint professional and technical
            employees, not to exceed 30 such employees at any time,
            to positions in the National Institutes of Health to
            perform, administer, or support qualified
            countermeasure research and development activities in
            carrying out this section.
              (2) Internal controls to be instituted.--The
            Secretary shall institute appropriate internal controls
            for appointments under this subsection.
      (f) Actions Committed to Agency Discretion.--Actions by the
    Secretary under the authority of this section are committed to
    agency discretion.

    SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

      (a) Strategic National Stockpile.--
              (1) In general.--The Secretary of Homeland Security
            (referred to in this section as the ``Homeland Security
            Secretary''), in coordination with the Secretary and
            the Secretary of Veterans Affairs, shall maintain a
            stockpile or stockpiles of drugs, vaccines and other
            biological products, medical devices, and other
            supplies in such numbers, types, and amounts as are
            determined by the Secretary to be appropriate and
            practicable, taking into account other available
            sources, to provide for the emergency health security
            of the United States, including the emergency health
            security of children and other vulnerable populations,
            in the event of a bioterrorist attack or other public
            health emergency.
              (2) Procedures.--The Secretary, in managing the
            stockpile under paragraph (1), shall--
                      (A) consult with the working group under
                    section 319F(a);
                      (B) ensure that adequate procedures are
                    followed with respect to such stockpile for
                    inventory management and accounting, and for
                    the physical security of the stockpile;
                      (C) in consultation with Federal, State, and
                    local officials, take into consideration the
                    timing and location of special events;
                      (D) review and revise, as appropriate, the
                    contents of the stockpile on a regular basis to
                    ensure that emerging threats, advanced
                    technologies, and new countermeasures are
                    adequately considered;
                      (E) devise plans for the effective and timely
                    supply-chain management of the stockpile, in
                    consultation with appropriate Federal, State
                    and local agencies, and the public and private
                    health care infrastructure; and
                      (F) ensure the adequate physical security of
                    the stockpile.
      (b) Smallpox Vaccine Development.--
              (1) In general.--The Secretary shall award contracts,
            enter into cooperative agreements, or carry out such
            other activities as may reasonably be required in order
            to ensure that the stockpile under subsection (a)
            includes an amount of vaccine against smallpox as
            determined by such Secretary to be sufficient to meet
            the health security needs of the United States.
              (2) Rule of construction.--Nothing in this section
            shall be construed to limit the private distribution,
            purchase, or sale of vaccines from sources other than
            the stockpile described in subsection (a).
      (c) Additional Authority Regarding Procurement of Certain
    Biomedical Countermeasures; Availability of Special Reserve
    Fund.--
              (1) In general.--
                      (A) Use of fund.--A security countermeasure
                    may, in accordance with this subsection, be
                    procured with amounts in the special reserve
                    fund under paragraph (10).
                      (B) Security countermeasure.--For purposes of
                    this subsection, the term ``security
                    countermeasure'' means a priority
                    countermeasure (as defined in section
                    319F(h))--
                              (i) against a chemical, biological,
                            radiological, or nuclear agent
                            identified as a material threat under
                            paragraph (2)(A)(ii);
                              (ii) that is determined under
                            paragraph (2)(B)(ii) to be a necessary
                            countermeasure;
                              (iii) that is designed, developed,
                            modified, or procured for the specific
                            purpose of preventing, detecting,
                            identifying, deterring, or mitigating
                            actual or potential acts of chemical,
                            biological, radiological, or nuclear
                            catastrophe;
                              (iv)(I) that is approved or cleared
                            under chapter V of the Federal Food,
                            Drug, and Cosmetic Act, or licensed
                            under section 351 of this Act, for use
                            as a countermeasure to a chemical,
                            biological, radiological, or nuclear
                            agent identified as a material threat
                            under paragraph (2)(A)(ii); or
                              (II) for which the Secretary
                            determines that sufficient and
                            satisfactory clinical experience or
                            research data (including data, if
                            available, from pre-clinical and
                            clinical trials) support a reasonable
                            conclusion that the countermeasure will
                            qualify for approval or licensing after
                            the date of a determination under
                            paragraph (5); and
                              (v) that relates to an actual or
                            potential act of terrorism or
                            catastrophic event or to actual or
                            potential warfare.
              (2) Determination of material threats.--
                      (A) Material threat.--The Homeland Security
                    Secretary, in consultation with the heads of
                    other agencies as appropriate, shall on an
                    ongoing basis--
                              (i) assess current and emerging
                            threats of chemical, biological,
                            radiological, and nuclear agents; and
                              (ii) determine which of such agents
                            present a material threat against the
                            United States population.
                      (B) Public health impact; necessary
                    countermeasures.--The Secretary shall on an
                    ongoing basis--
                              (i) assess the potential public
                            health consequences of use against the
                            United States population of agents
                            identified under subparagraph (A)(ii);
                            and
                              (ii) determine, on the basis of such
                            assessment, the agents for which
                            priority countermeasures are necessary
                            to protect the public health from a
                            material threat.
                      (C) Notice to congress.--The Secretary and
                    the Homeland Security Secretary shall promptly
                    notify the designated congressional committees
                    (as defined in paragraph (10)) of any
                    determination made pursuant to subparagraph (A)
                    or (B). Such notice shall be in unclassified
                    and, if necessary, classified form.
                      (D) Assuring access to threat information.--
                    In making the assessment and determination
                    required under subparagraph (A), the Homeland
                    Security Secretary shall use all information to
                    which such Secretary is entitled under section
                    202 of the Homeland Security Act of 2002,
                    including but not limited to information,
                    regardless of its level of classification,
                    relating to current and emerging threats of
                    chemical, biological, radiological, and nuclear
                    agents.
              (3) Assessment of availability and appropriateness of
            countermeasures.--The Secretary, in consultation with
            the Homeland Security Secretary, shall assess on an
            ongoing basis the availability and appropriateness of
            specific countermeasures to address specific threats
            identified under paragraph (2).
              (4) Call for development of countermeasures;
            commitment for recommendation for procurement.--
                      (A) Proposal to the president.--If, pursuant
                    to an assessment under paragraph (3), the
                    Homeland Security Secretary and the Secretary
                    make a determination that a countermeasure
                    would be appropriate but is either currently
                    unavailable for procurement or available under
                    unsuitable conditions, such Secretaries may
                    jointly submit to the President a proposal to--
                              (i) issue a call for the development
                            of such countermeasure; and
                              (ii) make a commitment that, upon the
                            first development of such
                            countermeasure that meets the
                            conditions for procurement under
                            paragraph (5), the Secretaries will,
                            based in part on information obtained
                            pursuant to such call, make a
                            recommendation under paragraph (6) that
                            the special reserve fund under
                            paragraph (10) be made available for
                            the procurement of such countermeasure.
                      (B) Countermeasure specifications.--The
                    Homeland Security Secretary and the Secretary
                    shall, to the extent practicable, include in
                    the proposal under subparagraph (A)--
                              (i) estimated quantity of purchase
                            (in the form of number of doses or
                            number of effective courses of
                            treatments regardless of dosage form);
                              (ii) necessary measures of minimum
                            safety and effectiveness;
                              (iii) estimated price for each dose
                            or effective course of treatment
                            regardless of dosage form; and
                              (iv) other information that may be
                            necessary to encourage and facilitate
                            research, development, and manufacture
                            of the countermeasure or to provide
                            specifications for the countermeasure.
                      (C) Presidential approval.--If the President
                    approves a proposal under subparagraph (A), the
                    Homeland Security Secretary and the Secretary
                    shall make known to persons who may respond to
                    a call for the countermeasure involved--
                              (i) the call for the countermeasure;
                              (ii) specifications for the
                            countermeasure under subparagraph (B);
                            and
                              (iii) a commitment described in
                            subparagraph (A)(ii).
              (5) Secretary's determination of countermeasures
            appropriate for funding from special reserve fund.--
                      (A) In general.--The Secretary, in accordance
                    with the provisions of this paragraph, shall
                    identify specific security countermeasures that
                    the Secretary determines, in consultation with
                    the Homeland Security Secretary, to be
                    appropriate for inclusion in the stockpile
                    under subsection (a) pursuant to procurements
                    made with amounts in the special reserve fund
                    under paragraph (10) (referred to in this
                    subsection individually as a ``procurement
                    under this subsection'').
                      (B) Requirements.--In making a determination
                    under subparagraph (A) with respect to a
                    security countermeasure, the Secretary shall
                    determine and consider the following:
                              (i) The quantities of the product
                            that will be needed to meet the needs
                            of the stockpile.
                              (ii) The feasibility of production
                            and delivery within five years of
                            sufficient quantities of the product.
                              (iii) Whether there is a lack of a
                            significant commercial market for the
                            product at the time of procurement,
                            other than as a security
                            countermeasure.
              (6) Recommendation for president's approval.--
                      (A) Recommendation for procurement.--In the
                    case of a security countermeasure that the
                    Secretary has, in accordance with paragraphs
                    (2), (3), and (5), determined to be appropriate
                    for procurement under this subsection, the
                    Homeland Security Secretary and the Secretary
                    shall jointly submit to the President, in
                    coordination with the Director of the Office of
                    Management and Budget, a recommendation that
                    the special reserve fund under paragraph (10)
                    be made available for the procurement of such
                    countermeasure.
                      (B) Presidential approval.--The special
                    reserve fund under paragraph (10) is available
                    for a procurement of a security countermeasure
                    only if the President has approved a
                    recommendation under subparagraph (A) regarding
                    the countermeasure.
                      (C) Notice to congress.--The Secretary and
                    the Homeland Security Secretary shall notify
                    the designated congressional committees of each
                    decision of the President to approve a
                    recommendation under subparagraph (A). Such
                    notice shall include an explanation of the
                    decision to make available the special reserve
                    fund under paragraph (10) for procurement of
                    such a countermeasure, including, where
                    available, the identification of the potential
                    supplier or suppliers of such countermeasure,
                    and whether other potential suppliers of the
                    same or similar countermeasures were considered
                    and rejected for procurement under this section
                    and the reasons therefor.
                      (D) Subsequent specific countermeasures.--
                    Procurement under this subsection of a security
                    countermeasure for a particular purpose does
                    not preclude the subsequent procurement under
                    this subsection of any other security
                    countermeasure for such purpose if the
                    Secretary has determined under paragraph (5)(A)
                    that such countermeasure is appropriate for
                    inclusion in the stockpile and if, as
                    determined by the Secretary, such
                    countermeasure provides improved safety or
                    effectiveness, or for other reasons enhances
                    preparedness to respond to threats of use of a
                    biological, chemical, radiological, or nuclear
                    agent. Such a determination by the Secretary is
                    committed to agency discretion.
                      (E) Rule of construction.--Recommendations
                    and approvals under this paragraph apply solely
                    to determinations that the special reserve fund
                    under paragraph (10) will be made available for
                    a procurement of a security countermeasure, and
                    not to the substance of contracts for such
                    procurement or other matters relating to awards
                    of such contracts.
              (7) Procurement.--
                      (A) In general.--For purposes of a
                    procurement under this subsection that is
                    approved by the President under paragraph (6),
                    the Homeland Security Secretary and the
                    Secretary shall have responsibilities in
                    accordance with subparagraphs (B) and (C).
                      (B) Interagency agreements.--
                              (i) For procurement.--The Homeland
                            Security Secretary shall enter into an
                            agreement with the Secretary for
                            procurement of a security
                            countermeasure in accordance with the
                            provisions of this paragraph. The
                            special reserve fund under paragraph
                            (10) shall be available for the
                            Secretary's costs of such procurement,
                            other than as provided in clause (ii).
                              (ii) For administrative costs.--The
                            agreement entered into between the
                            Homeland Security Secretary and the
                            Secretary for managing the stockpile
                            under subsection (a) shall provide for
                            reimbursement of the Secretary's
                            administrative costs relating to
                            procurements under this subsection.
                      (C) Procurement.--
                              (i) In general.--The Secretary shall
                            be responsible for--
                                      (I) arranging for procurement
                                    of a security countermeasure,
                                    including negotiating terms
                                    (including quantity, production
                                    schedule, and price) of, and
                                    entering into, contracts and
                                    cooperative agreements, and for
                                    carrying out such other
                                    activities as may reasonably be
                                    required, in accordance with
                                    the provisions of this
                                    subparagraph; and
                                      (II) promulgating regulations
                                    to implement clauses (v), (vi),
                                    and (vii), and any other
                                    provisions of this subsection.
                              (ii) Contract terms.--A contract for
                            procurements under this subsection
                            shall (or, as specified below, may)
                            include the following terms:
                                      (I) Payment conditioned on
                                    substantial delivery.--The
                                    contract shall provide that no
                                    payment may be made until
                                    delivery has been made of a
                                    substantial portion (as
                                    determined by the Secretary) of
                                    the total number of units
                                    contracted for, except that,
                                    notwithstanding any other
                                    provision of law, the contract
                                    may provide that, if the
                                    Secretary determines (in the
                                    Secretary's discretion) that an
                                    advance payment is necessary to
                                    ensure success of a project,
                                    the Secretary may pay an
                                    amount, not to exceed 10
                                    percent of the contract amount,
                                    in advance of delivery. The
                                    contract shall provide that
                                    such advance payment is
                                    required to be repaid if there
                                    is a failure to perform under
                                    the contract, except in special
                                    circumstances as determined by
                                    the Secretary on a contract by
                                    contract basis.
                                      (II) Contract duration.--The
                                    contract shall be for a period
                                    not to exceed five years,
                                    except that, in first awarding
                                    the contract, the Secretary may
                                    provide for a longer duration,
                                    not exceeding eight years, if
                                    the Secretary determines that
                                    complexities or other
                                    difficulties in performance
                                    under the contract justify such
                                    a period. The contract shall be
                                    renewable for additional
                                    periods, none of which shall
                                    exceed five years.
                                      (III) Storage by vendor.--The
                                    contract may provide that the
                                    vendor will provide storage for
                                    stocks of a product delivered
                                    to the ownership of the Federal
                                    Government under the contract,
                                    for such period and under such
                                    terms and conditions as the
                                    Secretary may specify, and in
                                    such case amounts from the
                                    special reserve fund under
                                    paragraph (10) shall be
                                    available for costs of
                                    shipping, handling, storage,
                                    and related costs for such
                                    product.
                                      (IV) Non-stockpile sales of
                                    security countermeasures.--The
                                    contract may provide that the
                                    vendor will not at any time
                                    (including after performance
                                    under the contract is otherwise
                                    completed) sell or otherwise
                                    provide such countermeasure to
                                    any domestic or foreign person,
                                    or transfer to any such person
                                    any quantity of such security
                                    countermeasure, or any
                                    intellectual property relating
                                    thereto that would enable the
                                    development or production of
                                    the countermeasure, without
                                    certification by the Secretary,
                                    in consultation with the
                                    Homeland Security Secretary,
                                    the Secretary of Defense, and
                                    the Secretary of State, that
                                    such sale or transfer, or
                                    category of sales or transfers,
                                    would not adversely affect the
                                    national security; and that,
                                    for each violation of this
                                    provision of the contract, the
                                    United States is entitled to
                                    recover from the person as
                                    liquidated damages an amount
                                    equal to three times the sum of
                                    the payments made to the vendor
                                    under the contract.
                              (iii) Availability of simplified
                            acquisition procedures.--
                                      (I) In general.--The amount
                                    of any procurement under this
                                    subsection shall be deemed to
                                    be below the threshold amount
                                    specified in section 4(11) of
                                    the Office of Federal
                                    Procurement Policy Act (41
                                    U.S.C. 403(11)), for purposes
                                    of application to such
                                    procurement, pursuant to
                                    section 302A(a) of the Federal
                                    Property and Administrative
                                    Services Act of 1949 (41 U.S.C.
                                    252a(a)), of--
                                              (aa) section
                                            303(g)(1)(A) of the
                                            Federal Property and
                                            Administrative Services
                                            Act of 1949 (41 U.S.C.
                                            253(g)(1)(A)) and its
                                            implementing
                                            regulations; and
                                              (bb) section 302A(b)
                                            of such Act (41 U.S.C.
                                            252a(b)) and its
                                            implementing
                                            regulations.
                                      (II) Application of certain
                                    provisions.--Notwithstanding
                                    subclause (I) and the provision
                                    of law and regulations referred
                                    to in such clause, each of the
                                    following provisions shall
                                    apply to procurements described
                                    in this clause to the same
                                    extent that such provisions
                                    would apply to such
                                    procurements in the absence of
                                    subclause (I):
                                              (aa) Chapter 37 of
                                            title 40, United States
                                            Code (relating to
                                            contract work hours and
                                            safety standards).
                                              (bb) Subsections (a)
                                            and (b) of Section 7 of
                                            the Anti-Kickback Act
                                            of 1986 (41 U.S.C.
                                            57(a) and (b)).
                                              (cc) Section 304C of
                                            the Federal Property
                                            and Administrative
                                            Services Act of 1949
                                            (41 U.S.C. 254d)
                                            (relating to the
                                            examination of
                                            contractor records).
                              (iv) Use of noncompetitive
                            procedures.--In addition to any other
                            authority to use procedures other than
                            competitive procedures, the Secretary
                            may use such other procedures for a
                            procurement under this subsection if
                            the product is available from only one
                            responsible source or only from a
                            limited number of responsible sources,
                            and no other type of product will
                            satisfy the Secretary's needs.
                              (v) Premium provision in multiple
                            award contracts.--
                                      (I) In general.--If, under
                                    this subsection, the Secretary
                                    enters into contracts with more
                                    than one vendor to procure a
                                    security countermeasure, such
                                    Secretary may, notwithstanding
                                    any other provision of law,
                                    include in each of such
                                    contracts a provision that--
                                              (aa) identifies an
                                            increment of the total
                                            quantity of security
                                            countermeasure
                                            required, whether by
                                            percentage or by
                                            numbers of units; and
                                              (bb) promises to pay
                                            one or more specified
                                            premiums based on the
                                            priority of such
                                            vendors' production and
                                            delivery of the
                                            increment identified
                                            under item (aa), in
                                            accordance with the
                                            terms and conditions of
                                            the contract.
                                      (II) Determination of
                                    government's requirement not
                                    reviewable.--If the Secretary
                                    includes in each of a set of
                                    contracts a provision as
                                    described in subclause (I),
                                    such Secretary's determination
                                    of the total quantity of
                                    security countermeasure
                                    required, and any amendment of
                                    such determination, is
                                    committed to agency discretion.
                              (vi) Extension of closing date for
                            receipt of proposals not reviewable.--A
                            decision by the Secretary to extend the
                            closing date for receipt of proposals
                            for a procurement under this subsection
                            is committed to agency discretion.
                              (vii) Limiting competition to sources
                            responding to request for
                            information.--In conducting a
                            procurement under this subsection, the
                            Secretary may exclude a source that has
                            not responded to a request for
                            information under section 303A(a)(1)(B)
                            of the Federal Property and
                            Administrative Services Act of 1949 (41
                            U.S.C. 253a(a)(1)(B)) if such request
                            has given notice that the Secretary may
                            so exclude such a source.
              (8) Interagency cooperation.--
                      (A) In general.--In carrying out activities
                    under this section, the Homeland Security
                    Secretary and the Secretary are authorized,
                    subject to subparagraph (B), to enter into
                    interagency agreements and other collaborative
                    undertakings with other agencies of the United
                    States Government.
                      (B) Limitation.--An agreement or undertaking
                    under this paragraph shall not authorize
                    another agency to exercise the authorities
                    provided by this section to the Homeland
                    Security Secretary or to the Secretary.
              (9) Restrictions on use of funds.--Amounts in the
            special reserve fund under paragraph (10) shall not be
            used to pay--
                      (A) costs for the purchase of vaccines under
                    procurement contracts entered into before the
                    date of the enactment of the Project BioShield
                    Act of 2003; or
                      (B) administrative costs.
              (10) Definitions.--
                      (A) Special reserve fund.--For purposes of
                    this subsection, the term ``special reserve
                    fund'' has the meaning given such term in
                    section 510 of the Homeland Security Act of
                    2002.
                      (B) Designated congressional committees.--For
                    purposes of this section, the term ``designated
                    congressional committees'' means the following
                    committees of the Congress:
                              (i) In the House of Representatives:
                            the Committee on Energy and Commerce,
                            the Committee on Appropriations, the
                            Committee on Government Reform, and the
                            Select Committee on Homeland Security
                            (or any successor to the Select
                            Committee).
                              (ii) In the Senate: the Committee on
                            Health, Education, Labor, and Pensions,
                            the Committee on Appropriations, and
                            the Committee on Government Affairs.
      (d) Disclosures.--No Federal agency shall disclose under
    section 552 of title 5, United States Code, any information
    identifying the location at which materials in the stockpile
    under subsection (a) are stored.
      (e) Definition.--For purposes of subsection (a), the term
    ``stockpile'' includes--
              (1) a physical accumulation (at one or more
            locations) of the supplies described in subsection (a);
            or
              (2) a contractual agreement between the Homeland
            Security Secretary and a vendor or vendors under which
            such vendor or vendors agree to provide to such
            Secretary supplies described in subsection (a).
      (f) Authorization of Appropriations.--
              (1) Strategic national stockpile.--For the purpose of
            carrying out subsection (a), there are authorized to be
            appropriated $640,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006. Such authorization is in addition to
            amounts in the special reserve fund under subsection
            (c)(10).
              (2) Smallpox vaccine development.--For the purpose of
            carrying out subsection (b), there are authorized to be
            appropriated $509,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.

               *       *       *       *       *       *       *

    TITLE IV--NATIONAL RESEARCH INSTITUTES

               *       *       *       *       *       *       *

    Part E--Other Agencies of NIH

               *       *       *       *       *       *       *

    SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

      (a) Modernization and Construction of Facilities.--
              (1) In general.--The Director of NIH, acting through
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases,
            may make grants or contracts to public and nonprofit
            private entities to expand, remodel, renovate, or alter
            existing research facilities or construct new research
            facilities, subject to the provisions of this section.

               *       *       *       *       *       *       *

      (c) Requirements for Grants.--
              (1) In general.--The Director of the Center or the
            Director of the National Institute of Allergy and
            Infectious Diseases may make a grant under subsection
            (a) only if the applicant for the grant meets the
            following conditions:
                      (A) * * *

               *       *       *       *       *       *       *

              (2) Institutions of emerging excellence.--From the
            amount appropriated under [subsection (i)] subsection
            (i)(1) for a fiscal year up to $50,000,000, the
            Director of the Center shall make available 25 percent
            of such amount, and from the amount appropriated under
            such subsection for a fiscal year that is over
            $50,000,000, the Director of the Center shall make
            available up to 25 percent of such amount, for grants
            under subsection (a) to applicants that in addition to
            meeting the requirements established in paragraph (1),
            have demonstrated emerging excellence in biomedical or
            behavioral research, as follows:
                      (A) * * *

               *       *       *       *       *       *       *

      (d) Requirement of Application.--The Director of the Center
    or the Director of the National Institute of Allergy and
    Infectious Diseases may make a grant under subsection (a) only
    if an application for the grant is submitted to the Director
    and the application is in such form, is made in such manner,
    and contains such agreements, assurances, and information as
    the Director determines to be necessary to carry out this
    section.
      (e) Amount of Grant; Payments.--
              (1) Amount.--The amount of any grant awarded under
            subsection (a) shall be determined by the Director of
            the Center or the Director of the National Institute of
            Allergy and Infectious Diseases, except that such
            amount shall not exceed--
                      (A) 50 percent (or, in the case of the
                    Institute, 75 percent) of the necessary cost of
                    the construction of a proposed facility as
                    determined by the Director; or
                      (B) in the case of a multipurpose facility,
                    40 percent (or, in the case of the Institute,
                    75 percent) of that part of the necessary cost
                    of construction that the Director determines to
                    be proportionate to the contemplated use of the
                    facility.
              (2) Reservation of amounts.--On the approval of any
            application for a grant under subsection (a), the
            Director of the Center or the Director of the National
            Institute of Allergy and Infectious Diseases shall
            reserve, from any appropriation available for such
            grants, the amount of such grant, and shall pay such
            amount, in advance or by way of reimbursement, and in
            such installments consistent with the construction
            progress, as the Director may determine appropriate.
            The reservation of any amount by the Director under
            this paragraph may be amended by the Director, either
            on the approval of an amendment of the application or
            on the revision of the estimated cost of construction
            of the facility.

               *       *       *       *       *       *       *

              (4) Waiver of limitations.--The limitations imposed
            under paragraph (1) may be waived at the discretion of
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases
            for applicants meeting the conditions described in
            subsection (c).
      (f ) Recapture of Payments.--If, not later than 20 years
    after the completion of construction for which a grant has been
    awarded under subsection (a)--
              (1) in the case of an award by the Director of the
            Center, the applicant or other owner of the facility
            shall cease to be a public or non profit private
            entity; or
              (2) the facility shall cease to be used for the
            research purposes for which it was constructed (unless
            the Director of the Center or the Director of the
            National Institute of Allergy and Infectious Diseases
            determines, in accordance with regulations, that there
            is good cause for releasing the applicant or other
            owner from obligation to do so),
    the United States shall be entitled to recover from the
    applicant or other owner of the facility the amount bearing the
    same ratio to the current value (as determined by an agreement
    between the parties or by action brought in the United States
    District Court for the district in which such facility is
    situated) of the facility as the amount of the Federal
    participation bore to the cost of the construction of such
    facility.

               *       *       *       *       *       *       *

      (i) Authorization of [Appropriations.--For the purpose of
    carrying out this section,] Appropriations.--
              (1) Center.--For the purpose of carrying out this
            section with respect to the Center, there are
            authorized to be appropriated $250,000,000 for fiscal
            year 2001, and such sums as may be necessary for each
            of the fiscal years 2002 and 2003.
              (2) National institute of allergy and infectious
            diseases.--For the purpose of carrying out this section
            with respect to the National Institute of Allergy and
            Infectious Diseases, there are authorized to be
            appropriated such sums as may be necessary for fiscal
            year 2003.
                                  ----------

                SECTION 510 OF THE HOMELAND SECURITY ACT OF 2002

    SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC
                        NATIONAL STOCKPILE.

      (a) Authorization of Appropriations.--For the procurement of
    security countermeasures under section 319F-2(c) of the Public
    Health Service Act (referred to in this section as the
    ``security countermeasures program''), there is authorized to
    be appropriated up to $5,593,000,000 for the fiscal years 2004
    through 2013. Of the amounts appropriated under the preceding
    sentence, not to exceed $3,418,000,000 may be obligated during
    the fiscal years 2004 through 2008, of which not to exceed
    $890,000,000 may be obligated during fiscal year 2004.
      (b) Special Reserve Fund.--For purposes of the security
    countermeasures program, the term ``special reserve fund''
    means the appropriations account established as a result of any
    appropriations made under subsection (a).
      (c) Availability.--
              (1) Integrity of special reserve fund; limitation of
            obligational authority to fund purposes; intent of
            congress against reprogramming.--Subject to paragraph
            (2), all amounts appropriated under subsection (a) are
            available for obligation through the end of fiscal year
            2013 and only for the specific purposes set forth in
            the security countermeasures program. It is the intent
            of the Congress that no portion of such amount that
            remains unobligated for such purposes shall be applied,
            through reprogramming or otherwise, to any other
            purpose.
              (2) Initial availability for particular
            procurements.--Amounts appropriated under subsection
            (a) become available for a procurement under the
            security countermeasures program only upon the approval
            by the President of such availability for the
            procurement in accordance with paragraph (6)(B) of such
            program.
      (d) Related Authorizations of Appropriations.--
              (1) Threat assessment capabilities.--For the purpose
            of carrying out the responsibilities of the Secretary
            for terror threat assessment under the security
            countermeasures program, there are authorized to be
            appropriated $5,000,000 for fiscal year 2004, and such
            sums as may be necessary for each of the fiscal years
            2005 and 2006, for the hiring of professional personnel
            within the Directorate for Information Analysis and
            Infrastructure Protection, who shall be analysts
            responsible for chemical, biological, radiological, and
            nuclear threat assessment (including but not limited to
            analysis of chemical, biological, radiological, and
            nuclear agents, the means by which such agents could be
            weaponized or used in a terrorist attack, and the
            capabilities, plans, and intentions of terrorists and
            other non-state actors who may have or acquire such
            agents). All such analysts shall meet the applicable
            standards and qualifications for the performance of
            intelligence activities promulgated by the Director of
            Central Intelligence pursuant to section 104 of the
            National Security Act of 1947.
              (2) Intelligence sharing infrastructure.--For the
            purpose of carrying out the acquisition and deployment
            of secure facilities (including information technology
            and physical infrastructure, whether mobile and
            temporary, or permanent) sufficient to permit the
            Secretary to receive, not later than December 31, 2003,
            all classified information and products to which the
            Under Secretary for Information Analysis and
            Infrastructure Protection is entitled under subtitle A
            of title II, there are authorized to be appropriated
            such sums as may be necessary for each of the fiscal
            years 2003 through 2006.
      (e) Emergency Development of Security Countermeasures.--If
    the Secretary of Homeland Security and the Secretary of Health
    and Human Services jointly determine that procurement of a
    security countermeasure that has been approved for procurement
    using the special reserve fund under subsection (a)--
              (1) is not proceeding at a sufficiently rapid pace
            under 319F-2 of the Public Health Service Act to
            protect the national security; or
              (2) could be produced significantly less expensively
            by the government directly than through procurements
            under such section;
    then amounts in the special reserve fund may be used by the
    Secretary of Health and Human Services to produce security
    countermeasures for placement in the stockpile under subsection
    (a) of section 319F-2 of such Act if the joint determination is
    submitted to the President and the President approves such use
    of the special reserve fund. Amounts made available for such
    use in accordance with the preceding sentence are available for
    obligation as of the date on which the presidential approval is
    made, subject to applicable law regarding the apportionment of
    appropriations. This subsection applies notwithstanding other
    provisions of this section, and notwithstanding section 319F-2
    of the Public Health Service Act. This subsection may not be
    construed as affecting the amounts specified in subsection (a)
    as authorizations of appropriations or the obligation limits
    contained therein.
                                  ----------

    SECTION 121 OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS
                            AND RESPONSE ACT OF 2002

    [SEC. 121. STRATEGIC NATIONAL STOCKPILE.

      [(a) Strategic National Stockpile.--
              [(1) In general.--The Secretary of Health and Human
            Services (referred to in this section as the
            ``Secretary''), in coordination with the Secretary of
            Veterans Affairs, shall maintain a stockpile or
            stockpiles of drugs, vaccines and other biological
            products, medical devices, and other supplies in such
            numbers, types, and amounts as are determined by the
            Secretary to be appropriate and practicable, taking
            into account other available sources, to provide for
            the emergency health security of the United States,
            including the emergency health security of children and
            other vulnerable populations, in the event of a
            bioterrorist attack or other public health emergency.
              [(2) Procedures.--The Secretary, in managing the
            stockpile under paragraph (1), shall--
                      [(A) consult with the working group under
                    section 319F(a) of the Public Health Service
                    Act;
                      [(B) ensure that adequate procedures are
                    followed with respect to such stockpile for
                    inventory management and accounting, and for
                    the physical security of the stockpile;
                      [(C) in consultation with Federal, State, and
                    local officials, take into consideration the
                    timing and location of special events;
                      [(D) review and revise, as appropriate, the
                    contents of the stockpile on a regular basis to
                    ensure that emerging threats, advanced
                    technologies, and new countermeasures are
                    adequately considered;
                      [(E) devise plans for the effective and
                    timely supply-chain management of the
                    stockpile, in consultation with appropriate
                    Federal, State and local agencies, and the
                    public and private health care infrastructure;
                    and
                      [(F) ensure the adequate physical security of
                    the stockpile.
      [(b) Smallpox Vaccine Development.--
              [(1) In general.--The Secretary shall award
            contracts, enter into cooperative agreements, or carry
            out such other activities as may reasonably be required
            in order to ensure that the stockpile under subsection
            (a) includes an amount of vaccine against smallpox as
            determined by the Secretary to be sufficient to meet
            the health security needs of the United States.
              [(2) Rule of construction.--Nothing in this section
            shall be construed to limit the private distribution,
            purchase, or sale of vaccines from sources other than
            the stockpile described in subsection (a).
      [(c) Disclosures.--No Federal agency shall disclose under
    section 552, United States Code, any information identifying
    the location at which materials in the stockpile under
    subsection (a) are stored.
      [(d) Definition.--For purposes of subsection (a), the term
    ``stockpile'' includes--
              [(1) a physical accumulation (at one or more
            locations) of the supplies described in subsection (a);
            or
              [(2) a contractual agreement between the Secretary
            and a vendor or vendors under which such vendor or
            vendors agree to provide to the Secretary supplies
            described in subsection (a).
      [(e) Authorization of Appropriations.--
              [(1) Strategic national stockpile.--For the purpose
            of carrying out subsection (a), there are authorized to
            be appropriated $640,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.
              [(2) Smallpox vaccine development.--For the purpose
            of carrying out subsection (b), there are authorized to
            be appropriated $509,000,000 for fiscal year 2002, and
            such sums as may be necessary for each of fiscal years
            2003 through 2006.]
                                  ----------

            SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

    SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

      (a) In General.--
              (1) Emergency uses.--Notwithstanding sections 505,
            510(k), and 515 of this Act and section 351 of the
            Public Health Service Act, and subject to the
            provisions of this section, the Secretary may authorize
            the introduction into interstate commerce, during the
            effective period of a declaration under subsection (b),
            of a drug or device intended for use in an actual or
            potential emergency (referred to in this section as an
            ``emergency use'').
              (2) Approval status of product.--An authorization
            under paragraph (1) may authorize an emergency use of a
            product that--
                      (A) is not approved, licensed, or cleared for
                    commercial distribution under a provision of
                    law referred to in such paragraph (referred to
                    in this section as an ``unapproved product'');
                    or
                      (B) is approved, licensed, or cleared under
                    such a provision, but which use is not under
                    such provision an approved, licensed, or
                    cleared use of the product (referred to in this
                    section as an ``unapproved use of an approved
                    product'').
              (3) Relation to other uses.--An emergency use
            authorized under paragraph (1) for a product is in
            addition to any other use that is authorized for the
            product under a provision of law referred to in such
            paragraph.
              (4) Definitions.--For purposes of this section:
                      (A) The term ``emergency use'' has the
                    meaning indicated for such term in paragraph
                    (1).
                      (B) The term ``product'' means a drug or
                    device.
                      (C) The term ``unapproved product'' has the
                    meaning indicated for such term in paragraph
                    (2)(A).
                      (D) The term ``unapproved use of an approved
                    product'' has the meaning indicated for such
                    term in paragraph (2)(B).
      (b) Declaration of Emergency.--
              (1) In general.--The Secretary may declare an
            emergency justifying the authorization under this
            subsection for a product on the basis of--
                      (A) a determination by the Secretary of
                    Homeland Security that there is a national
                    emergency, or a significant potential for a
                    national emergency, involving a heightened risk
                    of attack with a specified biological,
                    chemical, radiological, or nuclear agent or
                    agents;
                      (B) a determination by the Secretary of
                    Defense that there is a military emergency, or
                    a significant potential for a military
                    emergency, involving a heightened risk to
                    United States military forces of attack with a
                    biological, chemical, radiological, or nuclear
                    agent or agents; or
                      (C) a determination by the Secretary of a
                    public health emergency under section 319 of
                    the Public Health Service Act, affecting
                    national security and involving a specified
                    biological, chemical, radiological, or nuclear
                    agent or agents, or a specified disease or
                    condition that may be attributable to such
                    agent or agents.
              (2) Termination of declaration.--
                      (A) In general.--A declaration under this
                    subsection shall terminate upon the earlier
                    of--
                              (i) a determination by the Secretary,
                            in consultation as appropriate with the
                            Secretary of Homeland Security or the
                            Secretary of Defense, that the
                            circumstances described in paragraph
                            (1) have ceased to exist; or
                              (ii) the expiration of the one-year
                            period beginning on the date on which
                            the declaration is made.
                      (B) Renewal.--Notwithstanding subparagraph
                    (A), the Secretary may renew a declaration
                    under this subsection, and this paragraph shall
                    apply to any such renewal.
              (3) Advance notice of termination.--In terminating a
            declaration under this section, the Secretary shall
            provide advance notice that the declaration will be
            terminated. The period of advance notice shall be a
            period reasonably determined to provide--
                      (A) in the case of an unapproved product, a
                    sufficient period for disposition of shipments
                    of the product, including the return of such
                    shipments to the manufacturer (in the case of a
                    manufacturer that chooses to have the shipments
                    returned); and
                      (B) in the case of unapproved uses of
                    approved products, a sufficient period for the
                    disposition of any labeling that was provided
                    with respect to the emergency use involved.
              (4) Publication.--The Secretary shall promptly
            publish in the Federal Register each declaration,
            determination, and renewal under this subsection.
      (c) Criteria for Issuance of Authorization.--The Secretary
    may issue an authorization under this section with respect to
    the emergency use of a product only if, after consultation with
    the Director of the National Institutes of Health and the
    Director of the Centers for Disease Control and Prevention, to
    the extent feasible and appropriate given the circumstances of
    the emergency involved, the Secretary concludes--
              (1) that an agent specified in a declaration under
            subsection (b) can cause a serious or life-threatening
            disease or condition;
              (2) that, based on the totality of scientific
            evidence available to the Secretary, including data
            from adequate and well-controlled clinical trials, if
            available, it is reasonable to believe that--
                      (A) the product may be effective in
                    detecting, diagnosing, treating, or
                    preventing--
                              (i) such disease or condition; or
                              (ii) a serious or life-threatening
                            disease or condition caused by a
                            product authorized under this section
                            or approved under this Act or the
                            Public Health Service Act, for
                            detecting, diagnosing, treating, or
                            preventing such a disease or condition
                            caused by such an agent; and
                      (B) the known and potential benefits of the
                    product, when used to detect, diagnose,
                    prevent, or treat such disease or condition,
                    outweigh the known and potential risks of the
                    product;
              (3) that there is no adequate, approved, and
            available alternative to the product for detecting,
            diagnosing, preventing, or treating such disease or
            condition; and
              (4) that such other criteria as the Secretary may by
            regulation prescribe are satisfied.
      (d) Scope of Authorization.--
              (1) In general.--An authorization of a product under
            this section shall state--
                      (A) each disease or condition that the
                    product may be used to detect, diagnose,
                    prevent, or treat within the scope of the
                    authorization;
                      (B) the Secretary's conclusions, made under
                    subsection (c)(2)(B), that the known and
                    potential benefits of the product, when used to
                    detect, diagnose, prevent, or treat such
                    disease or condition, outweigh the known and
                    potential risks of the product; and
                      (C) the Secretary's conclusions, made under
                    subsection (c), concerning the safety and
                    potential effectiveness of the product in
                    detecting, diagnosing, preventing, or treating
                    such diseases or conditions, including an
                    assessment of the available scientific
                    evidence.
              (2) Confidential information.--Nothing in this
            section alters or amends section 1905 of title 18,
            United States Code, or section 552(b)(4) of title 5 of
            such Code.
      (e) Conditions of Authorization.--
              (1) Unapproved product.--
                      (A) Required conditions.--With respect to the
                    emergency use of an unapproved product, the
                    Secretary, to the extent feasible given the
                    circumstances of the emergency, shall, for
                    persons who choose to carry out one or more
                    activities for which the authorization is
                    issued, establish such conditions on an
                    authorization under this section as the
                    Secretary finds necessary or appropriate to
                    protect the public health, including the
                    following:
                              (i) Appropriate conditions designed
                            to ensure that, to the extent feasible
                            given the circumstances of the
                            emergency, health care professionals
                            administering the product are
                            informed--
                                      (I) that the Secretary has
                                    authorized the emergency use of
                                    the product;
                                      (II) of the significant known
                                    and potential benefits and
                                    risks of the emergency use of
                                    the product, and of the extent
                                    to which such benefits and
                                    risks are unknown; and
                                      (III) of the alternatives to
                                    the product that are available,
                                    and of their benefits and
                                    risks.
                              (ii) Appropriate conditions designed
                            to ensure that, to the extent feasible
                            given the circumstances of the
                            emergency, individuals to whom the
                            product is administered are informed--
                                      (I) that the Secretary has
                                    authorized the emergency use of
                                    the product;
                                      (II) of the significant known
                                    and potential benefits and
                                    risks of such use, and of the
                                    extent to which such benefits
                                    and risks are unknown; and
                                      (III) of the option to accept
                                    or refuse administration of the
                                    product, of the consequences,
                                    if any, of refusing
                                    administration of the product,
                                    and of the alternatives to the
                                    product that are available and
                                    of their benefits and risks.
                              (iii) Appropriate conditions for the
                            monitoring and reporting of adverse
                            events associated with the emergency
                            use of the product.
                              (iv) For manufacturers of the
                            product, appropriate conditions
                            concerning recordkeeping and reporting,
                            including records access by the
                            Secretary, with respect to the
                            emergency use of the product.
                      (B) Authority for additional conditions.--
                    With respect to the emergency use of an
                    unapproved product, the Secretary, to the
                    extent feasible given the circumstances of the
                    emergency, may, for persons who choose to carry
                    out one or more activities for which the
                    authorization is issued, establish such
                    conditions on an authorization under this
                    section as the Secretary finds necessary or
                    appropriate to protect the public health,
                    including the following:
                              (i) Appropriate conditions on which
                            entities may distribute the product
                            with respect to the emergency use of
                            the product (including limitation to
                            distribution by government entities),
                            and on how distribution is to be
                            performed.
                              (ii) Appropriate conditions on who
                            may administer the product with respect
                            to the emergency use of the product,
                            and on the categories of individuals to
                            whom, and the circumstances under
                            which, the product may be administered
                            with respect to such use.
                              (iii) For persons other than
                            manufacturers of the product,
                            appropriate conditions concerning
                            recordkeeping and reporting, including
                            records access by the Secretary, with
                            respect to the emergency use of the
                            product.
                              (iv) With respect to the emergency
                            use of the product, waive or limit, to
                            the extent appropriate given the
                            circumstances of the emergency,
                            conditions regarding current good
                            manufacturing practice otherwise
                            applicable to the manufacture,
                            processing, packing, or holding of
                            products subject to regulation under
                            this Act, including such requirements
                            established in section 501.
              (2) Unapproved use.--With respect to the emergency
            use of a product that is an unapproved use of an
            approved product:
                      (A) The Secretary may, for manufacturers of
                    the product who choose to carry out one or more
                    activities for which the authorization is
                    issued, establish any of the conditions
                    described in clauses (i) through (iv) of
                    paragraph (1)(A).
                      (B)(i) If the authorization under this
                    section regarding the emergency use authorizes
                    a change in the labeling of the product, but
                    the manufacturer of the product chooses not to
                    make such change, such authorization may not
                    authorize distributors of the product or any
                    other person to alter or obscure the labeling
                    provided by the manufacturer.
                      (ii) In the circumstances described in clause
                    (i), an authorization under this section
                    regarding the emergency use may, for persons
                    who do not manufacture the product and who
                    choose to act under this clause, authorize such
                    persons to provide information on the product
                    in addition to the labeling provided by the
                    manufacturer, subject to compliance with clause
                    (i). Such additional information shall not be
                    considered labeling for purposes of section
                    502.
      (f) Duration of Authorization.--
              (1) In general.--Except as provided in paragraph (2),
            an authorization under this section shall be effective
            until the earlier of the termination of the declaration
            under subsection (b) or a revocation under subsection
            (g).
              (2) Continued use after end of effective period.--An
            authorization shall continue to be effective for
            continued use with respect to patients to whom it was
            administered during the period described by paragraph
            (1), to the extent found necessary by such patients'
            attending physicians.
      (g) Revocation of Authorization.--
              (1) Review.--The Secretary shall periodically review
            the circumstances and the appropriateness of an
            authorization under this section.
              (2) Revocation.--The Secretary may revoke an
            authorization under this section if, in the Secretary's
            unreviewable discretion, the criteria under subsection
            (c) for issuance of such authorization are no longer
            met.
      (h) Publication.--The Secretary shall promptly publish in the
    Federal Register a notice of each authorization, and each
    termination or revocation of an authorization, and an
    explanation of the reasons therefor, under this section.
      (i) Actions Committed to Agency Discretion.--Actions under
    the authority of this section by the Secretary, by the
    Secretary of Defense, or by the Secretary of Homeland Security
    are committed to agency discretion.
      (j) Rules of Construction.--Nothing in this section shall be
    construed to impair or otherwise affect--
              (1) the authority of the President as Commander in
            Chief of the Armed Forces of the United States under
            article II, section 2 of the United States
            Constitution;
              (2) the authority of the Secretary of Defense with
            respect to the Department of Defense, including the
            armed forces, under other provisions of Federal law; or
              (3) the authority of the Secretary under section
            319F-2 to manage the stockpile under such section.
      (k) Application to Members of Armed Forces.--
              (1) Waiver of requirement relating to option to
            refuse.--In the case of administration of a
            countermeasure to members of the armed forces, a
            requirement, under subsection (e)(1)(A)(ii)(III),
            designed to ensure that individuals are informed of an
            option to accept or refuse administration of a product,
            may be waived by the President if the President
            determines, in writing, that complying with such
            requirement is not feasible, is contrary to the best
            interests of the members affected, or is not in the
            interests of national security.
              (2) Provision of information to member of the armed
            forces.--If the Secretary makes a determination that it
            is not feasible for the information required by
            subsection (e)(1)(A)(ii) to be provided to a member of
            the armed forces prior to the administration of the
            product, such information shall be provided to such
            member of the armed forces (or next-of-kin in the case
            of the death of a member) to whom the product was
            administered as soon as possible, but not later than 30
            days, after such administration. Information concerning
            the administration of the product shall be recorded in
            the medical record of the member.
              (3) Effect on statute pertaining to investigational
            new drugs.--In the case of an authorization based on a
            determination by the Secretary of Defense under
            subsection (b)(1)(B), section 1107 of title 10, United
            States Code, shall not apply to use of a product that
            is the subject of such authorization, within the scope
            of such authorization and while such authorization is
            effective.
      (l) Relation to Other Provisions.--If a product is the
    subject of an authorization under this section, the use of such
    product within the scope of the authorization--
              (1) shall not be subject to any requirements pursuant
            to section 505(i) or 520(g); and
              (2) shall not be subject to any requirements
            otherwise applicable to clinical investigations
            pursuant to other provisions of this Act.
      (m) Discretion Regarding Use of Authorization.--Nothing in
    this section provides the Secretary any authority to require
    any person to carry out any activity that becomes lawful
    pursuant to an authorization under this section, and no person
    is required to inform the Secretary that the person will not be
    carrying out such activity, except that a manufacturer of a
    sole-source unapproved product authorized for emergency use
    shall notify the Secretary within a reasonable period of time
    after the issuance by the Secretary of such authorization if
    such manufacturer does not intend to carry out an activity or
    activities under the authorization. This section does not have
    any legal effect on a person who does not carry out any
    activity for which an authorization under this section is
    issued, or who carries out such an activity pursuant to other
    provisions of this Act or section 351 of the Public Health
    Service Act.
      (n) Enforcement.--A person who carries out an activity
    pursuant to an authorization under this section, but who fails
    to comply with applicable conditions under subsection (e), is
    with respect to that act of noncompliance subject to the
    provisions of law specified in subsection (a) and to the
    enforcement of such provisions under section 301.